DOCSLIB.ORG

Integra™ Ruggles™-Redmond™ Neuro/Spine Surgical Instruments

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Integra™ Ruggles™-Redmond™ Neuro/Spine Surgical Instruments Integra™ Ruggles™-Redmond™ Neuro/Spine Surgical Instruments TABLE OF CONTENTS General Information Ordering & Warranty ..................................................................ii Trademarks ....................................................................................iii Scales ............................................................................................iv-v Instrument Measuring Guidelines ..................................... vi-viii Access Instrumentation .............................................1 Curettes ................................................................... 119 Cranial Burrs & Drills ...................................................................2 Ultra-Coat Curettes ................................................................ 120 Saws ..................................................................................................5 Spinal Fusion Curettes ............................................................ 122 Knives/Retinaculotome ................................................................7 Thoraco-Lumbar Curettes .................................................... 128 Dura Hooks ....................................................................................8 Extended Reach Curettes ...................................................... 128 Nerve Hooks ................................................................................10 Bone Cutters ............................................................................. 129 Separators .....................................................................................11 Cobb Style Curettes ................................................................ 129 Dissectors and Elevators ...........................................................13 Microsurgical Curettes ........................................................... 130 Osteotomes ................................................................................. 23 Ring Curettes .............................................................................132 Gouges .......................................................................................... 25 Bayonet Curettes ......................................................................133 Impactors .......................................................................................26 Cervical Axial Curettes .......................................................... 134 Lumbar Axial Curettes ........................................................... 136 Lumbar Bayonet Curettes ...................................................... 136 Retractors ..................................................................27 Anterior Cervical Fusion Distraction System ..................... 28 ACF System .................................................................................. 28 Suction Tubes .......................................................... 137 MLD System ..................................................................................33 Frazier Suction Tubes .............................................................. 136 UMLD System ............................................................................. 34 Poppen Suction Tubes ..............................................................141 Flexi-Spine™ Retraction System .............................................36 Multi-Hole Suction Tubes ...................................................... 142 RUGGLES™ Spinal Retraction System ................................. 38 Endonasal Suction Tubes ........................................................ 144 LumbarTrak Retractor System ..................................................40 Bayonet Suction Tubes ............................................................ 145 Spetzler Sonntag Trans-Oral Retractor System ....................44 Tapered Teardrop Suction Tubes ......................................... 146 McCulloch Retractor System ....................................................49 Spatulas ...........................................................................................51 Nerve Root ...................................................................................55 Microsurgical Instrumentation .............................149 Hand-Held .................................................................................... 58 Micro Dissection ...................................................................... 150 Spreaders .......................................................................................62 Micro Titanium ...........................................................................169 Scalp ............................................................................................... 64 Micro Hooks .............................................................................. 172 Self-Retaining ............................................................................... 65 Micro Forceps ............................................................................176 Traction Tongs .............................................................................76 Bipolar Forceps ......................................................................... 180 Micro Scissors ............................................................................193 Micro Needle Holders ............................................................200 Rongeurs ....................................................................77 Ring Handled Forceps and Scissors .....................................204 Bone Rongeurs .............................................................................78 Speculums ...................................................................................208 Wire Cutters ............................................................................... 86 Transphenoidal ..........................................................................209 Intervertebral Disc Rongeurs ..................................................87 Endonasal .....................................................................................213 Micro Kerrison Rongeurs ........................................................ 99 Bayonet Kerrison Rongeurs ................................................... 103 Indexes ..................................................................... 215 Medium Kerrison Rongeurs ...................................................104 Alphabetical Index .....................................................................216 Spurling Kerrison Rongeurs ....................................................107 Numerical Index .......................................................................220 Ferris-Smith Kerrisons Rongeurs ..........................................112 Ejector Kerrisons ......................................................................113 Curved Kerrison ........................................................................115 Toll Free: (877) 468-5572 Fax: (800) 275-7192 www.integralife.com i ORDERING AND WARRANTY Pricing: Return Policy: Prices stated in specific written quotations are firm for thirty days • Authorization, from customer service, must be obtained prior from the date given, and are otherwise subject to change without to returning product within 90 days of receipt of product. prior notice. Pricing terms stated on written agreements are governed by such agreements. • Sterile product must be returned in unopened, undamaged cartons, packed to prevent damage. Shipments: • Non-sterile product must be returned in unused saleable F.O.B. Integra LifeSciences point of shipment within the continental condition in original package. United States. Shipping costs (including freight and insurance), shall be prepaid by Integra LifeSciences and invoiced to customers. • Credit will be issued for goods returned prior to ninety days from ship date with a 20% restocking charge. This Ordering Procedure: assumes that the product returned is not damaged and can be verified to have not been used or opened. A written purchase order on customer’s form may be requested for purchases of Integra LifeSciences products. Acceptance of Orders: For Product Instructions for Use, please visit www.integralife.com/jarit Orders are accepted upon approval by Integra LifeSciences. Integra Standard Warranty INTEGRA LIFESCIENCES CORPORATION ("INTEGRA") warrants to the original purchaser only that each new INTEGRA product is free from manufacturing defects in material and workmanship under normal use and service for a period of two (2) years (except as otherwise expressly provided as to accessory items) from the date of delivery by INTEGRA to the first purchaser, but in no event beyond the expiration date stated on any product labeling. Surgical instruments are guaranteed to be free from defects in material and workmanship when maintained and cleaned properly and used normally for their intended purpose. Any covered product that is placed by INTEGRA under a lease, rental or installment purchase agreement and that requires repair service during the term of such placement agreement shall be repaired in accordance with the terms of such agreement. If any covered defect occurs during the warranty period or term of such placement agreement, the purchaser should communicate directly with INTEGRA’s home office. If purchaser seeks to invoke the terms of this warranty, the product must be returned to INTEGRA at its home office. The defective product should be returned promptly, properly packaged and
Load more

Recommended publications
  • Landmarks in the History of Neurosurgery
    PART 1 General Overview 1 Landmarks in the History of Neurosurgery JAMES TAIT GOODRICH “If a physician makes a wound and cures a freeman, he shall receive ten running complex 21st-century stereotaxic frameless guided pieces of silver, but only five if the patient is the son of a plebeian or two systems. if he is a slave. However it is decreed that if a physician treats a patient In many museum and academic collections around the with a metal knife for a severe wound and has caused the man to die—his world are examples of the earliest form of neurosurgery—skull hands shall be cut off.” trephination.1–4 A number of arguments and interpretations —Code of Hammurabi (1792–50 BC) have been advanced by scholars as to the origin and surgical reasons for this early operation—to date no satisfactory answers have been found. Issues of religion, treatment of head injuries, release of demons, and treatment of headaches have all been offered. Unfortunately, no adequate archaeological materials n the history of neurosurgery there have occurred a number have surfaced to provide us with an answer. In reviewing some of events and landmarks, and these will be the focus of this of the early skulls, the skills of these early surgeons were quite chapter. In understanding the history of our profession, remarkable. Many of the trephined skulls show evidence of Iperhaps the neurosurgeon will be able explore more carefully healing, proving that these early patients survived the surgery. the subsequent chapters in this volume to avoid having his or Fig.
    [Show full text]
  • 434 Part 882—Neurological Devices
    Pt. 882 21 CFR Ch. I (4–1–12 Edition) PART 882—NEUROLOGICAL 882.1950 Tremor transducer. DEVICES Subparts C–D [Reserved] Subpart A—General Provisions Subpart E—Neurological Surgical Devices Sec. 882.4030 Skull plate anvil. 882.1 Scope. 882.4060 Ventricular cannula. 882.3 Effective dates of requirement for pre- 882.4100 Ventricular catheter. market approval. 882.4125 Neurosurgical chair. 882.9 Limitations of exemptions from sec- 882.4150 Scalp clip. tion 510(k) of the Federal Food, Drug, 882.4175 Aneurysm clip applier. and Cosmetic Act (the act). 882.4190 Clip forming/cutting instrument. 882.4200 Clip removal instrument. Subpart B—Neurological Diagnostic 882.4215 Clip rack. Devices 882.4250 Cryogenic surgical device. 882.4275 Dowel cutting instrument. 882.1020 Rigidity analyzer. 882.4300 Manual cranial drills, burrs, 882.1030 Ataxiagraph. trephines, and their accessories. 882.1200 Two-point discriminator. 882.4305 Powered compound cranial drills, 882.1240 Echoencephalograph. burrs, trephines, and their accessories. 882.1275 Electroconductive media. 882.4310 Powered simple cranial drills, 882.1310 Cortical electrode. burrs, trephines, and their accessories. 882.1320 Cutaneous electrode. 882.4325 Cranial drill handpiece (brace). 882.1330 Depth electrode. 882.4360 Electric cranial drill motor. 882.1340 Nasopharyngeal electrode. 882.4370 Pneumatic cranial drill motor. 882.1350 Needle electrode. 882.4400 Radiofrequency lesion generator. 882.1400 Electroencephalograph. 882.4440 Neurosurgical headrests. 882.1410 Electroencephalograph electrode/ 882.4460 Neurosurgical head holder (skull lead tester. clamp). 882.1420 Electroencephalogram (EEG) signal 882.4500 Cranioplasty material forming in- spectrum analyzer. strument. 882.1430 Electroencephalograph test signal 882.4525 Microsurgical instrument. generator. 882.1460 Nystagmograph.
    [Show full text]
  • SURGICAL INSTRUMENT CATALOG Codman SURGICAL PRODUCTS CATALOG
    SURGICAL INSTRUMENT CATALOG Codman SURGICAL PRODUCTS CATALOG © Codman & Shurtleff, Inc. 2008 All Rights Reserved Printed in U.S.A. TERMS OF SALE A. ORDERING INFORMATION 3. Warranty Repair and Restore products are warranted to be free Purchase orders may be addressed to: from defects in workmanship and material with respect Johnson & Johnson Health Care Systems, Inc. to the Repair and Restore only, and not with respect to 425 Hoes Lane, P.O. Box 6800 the original instrument. Piscataway, NJ 08855-6800 Attn: Customer Service C. SPECIAL ORDERS or telephoned to Johnson & Johnson Health Care Systems, Inc. Service Department toll free number Products that have been discontinued by Codman, 1-800-255-2500. Orders may also be placed with your may be available through our Repair Department. local Codman sales representative. Codman’s Special Devices Department provides hospi- To insure accuracy in ordering, please include the tals and surgeons with surgical instrumentation cus- following information when placing your order: tomized to individual specifications. 1. Catalog Number Order forms for Special Devices can be obtained from 2. Quantity your sales representative or by directly contacting the 3. Product Description Special Order Department at 1-800-843-0039. 4. Your Customer Number* For pricing, delivery, and more information regarding 5. Complete Billing and Shipping Addresses special order products, please call the Special Order 6. Special Instructions (i.e.: etching, method Department at 1-800-843-0039. of shipment) *Your customer Number can be provided to you by Johnson & Johnson Health Care Systems, Inc. Customer Service Department. All orders are subject to acceptance by Codman & Shurtleff, Inc./Johnson & Johnson D.
    [Show full text]
  • Impact of Virtual Reality in Arterial Anatomy Detection and Surgical Planning in Patients with Unruptured Anterior Communicating Artery Aneurysms
    brain sciences Article Impact of Virtual Reality in Arterial Anatomy Detection and Surgical Planning in Patients with Unruptured Anterior Communicating Artery Aneurysms Samer Zawy Alsofy 1,2,* , Ioanna Sakellaropoulou 2, Makoto Nakamura 3, Christian Ewelt 2, Asem Salma 4, Marc Lewitz 2, Heinz Welzel Saravia 2, Hraq Mourad Sarkis 2, Thomas Fortmann 2 and Ralf Stroop 1 1 Department of Medicine, Faculty of Health, Witten/Herdecke University, 58448 Witten, Germany; [email protected] 2 Department of Neurosurgery, St. Barbara-Hospital, Academic Hospital of Westfälische Wilhelms-University Münster, 59073 Hamm, Germany; [email protected] (I.S.); [email protected] (C.E.); [email protected] (M.L.); [email protected] (H.W.S.); [email protected] (H.M.S.); [email protected] (T.F.) 3 Department of Neurosurgery, Academic Hospital Köln-Merheim, Witten/Herdecke University, 51109 Köln, Germany; [email protected] 4 Department of Neurosurgery, St. Rita’s Neuroscience Institute, Lima, OH 45801, USA; [email protected] * Correspondence: [email protected] Received: 1 November 2020; Accepted: 8 December 2020; Published: 10 December 2020 Abstract: Anterior-communicating artery (ACoA) aneurysms have diverse configurations and anatomical variations. The evaluation and operative treatment of these aneurysms necessitates a perfect surgical strategy based on review of three-dimensional (3D) angioarchitecture using several radiologic imaging methods. We analyzed the influence of 3D virtual reality (VR) reconstructions versus conventional computed tomography angiography (CTA) scans on the identification of vascular anatomy and on surgical planning in patients with unruptured ACoA aneurysms. Medical files were retrospectively analyzed regarding patient- and disease-related data. Preoperative CTA scans were retrospectively reconstructed to 3D-VR images and visualized via VR software to detect the characteristics of unruptured ACoA aneurysms.
    [Show full text]
  • 394 Part 882—Neurological Devices
    Pt. 882 21 CFR Ch. I (4–1–01 Edition) subpart E of part 807 of this chapter 882.1900 Evoked response auditory stimu- subject to the limitations in § 880.9. lator. 882.1925 Ultrasonic scanner calibration test [63 FR 59718, Nov. 5, 1998] block. 882.1950 Tremor transducer. PART 882—NEUROLOGICAL DEVICES Subparts C–D [Reserved] Subpart E—Neurological Surgical Devices Subpart A—General Provisions 882.4030 Skull plate anvil. Sec. 882.4060 Ventricular cannula. 882.1 Scope. 882.4100 Ventricular catheter. 882.3 Effective dates of requirement for pre- 882.4125 Neurosurgical chair. market approval. 882.4150 Scalp clip. 882.9 Limitations of exemptions from sec- 882.4175 Aneurysm clip applier. tion 510(k) of the Federal Food, Drug, 882.4190 Clip forming/cutting instrument. and Cosmetic Act (the act). 882.4200 Clip removal instrument. 882.4215 Clip rack. Subpart B—Neurological Diagnostic 882.4250 Cryogenic surgical device. Devices 882.4275 Dowel cutting instrument. 882.4300 Manual cranial drills, burrs, 882.1020 Rigidity analyzer. trephines, and their accessories. 882.1030 Ataxiagraph. 882.4305 Powered compound cranial drills, 882.1200 Two-point discriminator. burrs, trephines, and their accessories. 882.1240 Echoencephalograph. 882.4310 Powered simple cranial drills, 882.1275 Electroconductive media. burrs, trephines, and their accessories. 882.1310 Cortical electrode. 882.4325 Cranial drill handpiece (brace). 882.1320 Cutaneous electrode. 882.4360 Electric cranial drill motor. 882.1330 Depth electrode. 882.4370 Pneumatic cranial drill motor. 882.1340 Nasopharyngeal electrode. 882.4400 Radiofrequency lesion generator. 882.1350 Needle electrode. 882.4440 Neurosurgical headrests. 882.1400 Electroencephalograph. 882.4460 Neurosurgical head holder (skull 882.1410 Electroencephalograph electrode/ clamp).
    [Show full text]
  • Neurosurgical Head Holder (Skull Clamp)
    Food and Drug Administration, HHS § 882.4460 nervous tissue by the application of ex- (b) Classification. Class I (general con- treme cold to the selected site. trols). The device is exempt from the (b) Classification. Class II (perform- premarket notification procedures in ance standards). subpart E of part 807 of this chapter subject to the limitations in § 882.9. § 882.4275 Dowel cutting instrument. [44 FR 51730–51778, Sept. 4, 1979, as amended (a) Identification. A dowel cutting in- at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July strument is a device used to cut dowels 25, 2001] of bone for bone grafting. (b) Classification. Class II (perform- § 882.4360 Electric cranial drill motor. ance standards). (a) Identification. An electric cranial drill motor is an electrically operated § 882.4300 Manual cranial drills, burrs, power source used with removable ro- trephines, and their accessories tating surgical cutting tools or drill (a) Identification. Manual cranial bits on a patient’s skull. drills, burrs, trephines, and their acces- (b) Classification. Class II (perform- sories are bone cutting and drilling in- ance standards). struments that are used without a power source on a patient’s skull. § 882.4370 Pneumatic cranial drill motor. (b) Classification. Class II (perform- ance standards). (a) Identification. A pneumatic cranial drill motor is a pneumatically operated § 882.4305 Powered compound cranial power source used with removable ro- drills, burrs, trephines, and their tating surgical cutting tools or drill accessories. bits on a patient’s skull. (a) Identification. Powered compound (b) Classification. Class II (perform- cranial drills, burrs, trephines, and ance standards).
    [Show full text]
  • The Choice of the Best Surgical Approach Remains Critical Despite the Technological Revolution
    Revisión de Temas https://doi.org/10.36593/rev.chil.neurocir.v46i1.185 The choice of the best surgical approach remains critical despite the technological revolution La selección del mejor abordaje sigue siendo fundamental pese a la revolución tecnológica Allan J. Drapkin, MD, FACS(R)1 1 Department of Surgery (Neurosurgery), Jersey Shore University Medical Center Neptune. New Jersey, USA. Resumen Este trabajo describe brevemente la Neurocirugía a mediados del siglo XX, en cuanto a Instrumental disponible y a los elementos de apoyo diagnóstico entonces existentes. Luego evalúa el impacto progresivo que la neurocirugía ha experimentado durante este período como resultado de la revolución tecnológica, destacando el hecho de que a pesar de estas sucesivas innovaciones, la selección del mejor abordaje quirúrgico en cada caso individual, basado en la neuroanatomía relacionada ha retenido una gran importancia. Palabras clave: Tecnología, progreso, abordaje quirúrgico. Abstract Following a brief description of the state of Neurosurgery in the mid XX Century, regarding both the instrumentation as well as the means of diagnosis existent at that time, an evaluation is made of the progressive impact that Neurosurgery has experienced as a consequence of the technological revolution, stressing the fact that, despite of the successive innovations experienced during this period, the selection of the surgical approach in each particular case has retained a great importance. Key words: Technology, progress, surgical approach. The technological explosion which has evolved during the bordering the limits of the planned craniotomy and then each past fifty years has clearly changed dramatically our specialty. pair of these burr holes had to be interconnected by manu- These advances have emerged both based on the accumulat- ally pulled saw wires which were used to cut the skull along a ing knowledge in neuroanatomy21 and function as well as in line connecting those burr holes.
    [Show full text]
  • Customer Discovery 120+ Interviews
    Customer Discovery 120+ Interviews Summer 2020 CONFIDENTIAL Use of material without permission strictly prohibited. Table of Contents 1. Key Needs Part 1 2. Competitor Analysis 3. Hubly Analysis Click to go to 4. Purchasing Pathway each section Part 2 5. Marketing Strategy 6. Hubly Marketing 7. Appendix Customer Discovery Part 1 Overview Using “Three Why’s” we analyzed competitors and Hubly’s technology with key surgeon needs to create a value proposition Why buy anything? Why buy Hubly? Why buy now? Understanding the priorities and Using the six key needs and We ideated marketing leverage needs of surgeons helped inform background research we analyzed points that address unmet needs with us on ways to answer why they Hubly and its competitors on how current drills that would motivate buy new drills well they address surgeon needs surgeons to “buy now” Part 1 Overview | Key Needs | Competitors | Hubly Key Needs Key Needs Interviews We employed the following methodology to identify surgeon preferences and, ultimately, our key needs for drills Buying Process • How much of a say do surgeons have in buying drills? • How often are new drills bought? Hospital Physicians (62) Residents (15) Administrators (14) • How do surgeons get information on new Click to edit Master subtitle style drills? Current Drills • What drills have you used? • What qualities do you look for in drills? • What specific qualities do you look for in single use drills? Technological Features • What new technologies are needed? • Would you like plunge prevention and finer
    [Show full text]
  • 384 Part 882—Neurological Devices
    § 880.6990 21 CFR Ch. I (4±1±99 Edition) § 880.6990 Infusion stand. 882.1825 Rheoencephalograph. 882.1835 Physiological signal amplifier. (a) Identification. The infusion stand 882.1845 Physiological signal conditioner. is a stationary or movable stand in- 882.1855 Electroencephalogram (EEG) te- tended to hold infusion liquids, infu- lemetry system. sion accessories, and other medical de- 882.1870 Evoked response electrical stimu- vices. lator. (b) Classification. Class I (general con- 882.1880 Evoked response mechanical stimu- lator. trols). The device is exempt from the 882.1890 Evoked response photic stimulator. premarket notification procedures in 882.1900 Evoked response auditory stimu- subpart E of part 807 of this chapter lator. subject to the limitations in § 880.9. 882.1925 Ultrasonic scanner calibration test block. [63 FR 59718, Nov. 5, 1998] 882.1950 Tremor transducer. PART 882ÐNEUROLOGICAL Subparts C±D [Reserved] DEVICES Subpart EÐNeurological Surgical Devices Subpart AÐGeneral Provisions 882.4030 Skull plate anvil. 882.4060 Ventricular cannula. Sec. 882.4100 Ventricular catheter. 882.1 Scope. 882.4125 Neurosurgical chair. 882.3 Effective dates of requirement for pre- 882.4150 Scalp clip. market approval. 882.4175 Aneurysm clip applier. 882.9 Limitations of exemptions from sec- 882.4190 Clip forming/cutting instrument. tion 510(k) of the Federal Food, Drug, 882.4200 Clip removal instrument. and Cosmetic Act (the act). 882.4215 Clip rack. 882.4250 Cryogenic surgical device. Subpart BÐNeurological Diagnostic 882.4275 Dowel cutting instrument. Devices 882.4300 Manual cranial drills, burrs, trephines, and their accessories. 882.1020 Rigidity analyzer. 882.4305 Powered compound cranial drills, 882.1030 Ataxiagraph.
    [Show full text]
  • 2016-Complete-Catalog.Pdf
    ® MEDFIX INTERNATIONAL, LLC ® MEDFIX International, LLC Spine / Ortho / General Surgical Instrumentation Guide ® medfix International LLC / www.medfix.com / 866.321.6331 3 ® MEDFIX International, LLC Reducing cost without compromising quality. - Medfix Founder medfix® International LLC / www.medfix.com / 866.321.6331 5 ® MEDFIX International, LLC Medfix International, LLC has been delivering quality, low cost instrumentation around the world for many years. As a result of our success in fulfilling our mission of reducing cost without compromising quality, we have been able to partner with the biggest suppliers in the United States and Germany for the distribution of general surgical instrumentation. With over 14,000 items in stock and an expanding catalog with thousands of instruments, we can outfit anything from a single suture removal station to the largest multi-discipline operating room anywhere in the world, from simple forceps to procedure-specific instrumentation trays. We can cross-reference almost any surgical instrument in the world by company and part number. The vast majority of our orders are shipped within 3 business days. If you want to reduce costs, improve lead times, and remove guesswork from outfitting your surgical service, contact us and find out how easy it is to do business with a leader in the industry. QUALITY ASSURANCE Our instruments are manufactured from the highest quality German surgical stainless steel (ASTM F899), are treated to be corrosion resistant, and meet or exceed the most stringent of FDA and CE certifications. Our instruments have been tested with the Thermo Scientific™ Niton XL3t XRF analyzer and show no significant variation from industry standard for type 420 stainless steel.
    [Show full text]
  • Global Tender Enquiry Document
    TENDER ENQUIRY DOCUMENT FOR PURCHASE OF MEDICAL EQUIPMENT FOR INSTITUTIONS GETTING UPGRADED UNDER PMSSY PHASE III On behalf of GOVT. OF INDIA MINISTRY OF HEALTH & FAMILY WELFARE HITES/PCD/PMSSY-III/31/NRSG/18-19 Through HLL INFRA TECH SERVICES LIMITED (Subsidiary of HLL Lifecare Ltd., a Govt. of India Enterprise) B-14 A, Sector-62, Noida - 201 307 Phone: 0120-4071500; Fax: 0120-4071513 URL: www.hllhites.com Email: [email protected] HLL Infra Tech Services Limited INDEX Section Topic Page No. Section I – Notice inviting e-Tender (e-NIT) ------------------------------------------------------- 03 Section II – General Instructions to Tenderers (GIT) ----------------------------------------------- 05 Section III – Special Instructions to Tenderers (SIT) ------------------------------------------------ 26 Section IV – General Conditions of Contract (GCC) ------------------------------------------------ 27 Section V – Special Conditions of Contract (SCC) ------------------------------------------------- 42 Section VI – List of Requirements --------------------------------------------------------------------- 43 Section VII – Technical Specifications ----------------------------------------------------------------- 45 Section VIII – Quality Control Requirements -------------------------------------------------------- 77 Section IX – Qualification Criteria ---------------------------------------------------------------------- 78 Section X – Tender Form -------------------------------------------------------------------------------- 80 Section XI
    [Show full text]
  • CODMAN® Cranial Hand Drill and Cranial Drill Bits
    CODMAN® Cranial Hand Drill and Cranial Drill Bits Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048 USA Integra LifeSciences Services (France) Immeuble Séquoïa 2 97 Allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest – France 2797 LCN 183299-001 Rev K 04/19 1290688-1 © 2019 Integra LifeSciences Corporation. All rights reserved. CODMAN Cranial Hand Drill and Cranial Drill Bits 1 2 i ENGLISH IMPORTANT INFORMATION Please Read Before Use CODMAN® Cranial Hand Drill and Cranial Drill Bits CODMAN Cranial Hand Drill 5.8 mm Cranial Drill Bit 2.7 mm Cranial Drill Bit Indications The CODMAN® Cranial Hand Drill and Cranial Drill Bits are indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Contraindications This device is not designed, sold, or intended for any use except as indicated. Complications Bleeding may occur at the site of the drill hole, originating from the scalp, bone, dural, or cerebral areas. Due to the possibility of cerebral or extracerebral hemorrhage or any other complication of this procedure, drill hole placement is the sole responsibility of the attending neurosurgeon. PRECAUTIONS It is essential to maintain strict aseptic technique during craniotomy procedures. Description The following products are available separately: CODMAN Cranial Hand Drill 82-6607 5.8 mm Cranial Drill Bit 82-6608 2.7 mm Cranial Drill Bit 82-6609 Each of the drill bits is packaged with a drill guide and a hex wrench. 1 Instructions for Use 1. After prepping and draping the patient, perform the incision and retraction techniques required to expose the skull.
    [Show full text]