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Información Del Documento Original República De Colombia Ministerio De Salud Y Protección Social Instituto Nacional De Vigilancia De Medicamentos Y Alimentos – INVIMA

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Información Del Documento Original República De Colombia Ministerio De Salud Y Protección Social Instituto Nacional De Vigilancia De Medicamentos Y Alimentos – INVIMA República de Colombia Ministerio de Salud y Protección Social Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA RESOLUCIÓN No. 2018051075 DE 23 de Noviembre de 2018 Por la cual se concede un Registro Sanitario El Director técnico de Dispositivos Médicos y otras Tecnologías del Instituto Nacional de Vigilancia de Medicamentos y Alimentos INVIMA, en ejercicio de las facultades Legales conferidas en el Decreto 2078 de 2012, decreto Reglamentario 4725 de 2005, ley 1437 de 2011 y ley 962 de 2005 CONSIDERANDO QUE ANTE ESTE INSTITUTO SE HA SOLICITADO LA CONCESIÓN DE UN REGISTRO SANITARIO AUTOMATICO CON BASE EN LA VERIFICACIÓN DE LA DOCUMENTACIÓN TÉCNICO LEGAL ALLEGADA ANTE LA DIRECCIÓN DE DISPOSITIVOS MÉDICOS Y OTRAS TECNOLOGÍAS, EMITIENDO CONCEPTO FAVORABLE PARA LA EXPEDICIÓN DE ESTE REGISTRO SANITARIO. EN CONSECUENCIA A LO ANTERIOR, DE CONFORMIDAD CON EL ARTICULO 57 DE LA LEY 962 DE 2005 EL INVIMA REALIZARA EL CONTROL POSTERIOR DENTRO DE LOS QUINCE (15) DIAS SIGUIENTES A SU EXPEDICIÓN. RESUELVE ARTICULO PRIMERO.- Conceder REGISTRO SANITARIO por el término de DIEZ (10) años a PRODUCTO: INSTRUMENTAL QUIRURGICO Marca: KREBS REGISTRO SANITARIO No.: INVIMA 2018DM-0018976 TIPO DE REGISTRO: IMPORTAR Y VENDER TITULAR(ES): CORPORACION SURGYSTORE SAS con domicilio en VALLEDUPAR - CESAR FABRICANTE(S): VITRA INTERNATIONAL con domicilio en PAKISTAN IMPORTADOR(ES): CORPORACION SURGYSTORE SAS con domicilio en VALLEDUPAR - CESAR ACONDICIONADOR(ES): LOGICALL S.A con domicilio en BOGOTA - D.C. TIPO DE DISPOSITIVO INVASIVO RIESGO: I COMPOSICIÓN: COMPOSICIÓN CUALITATIVA CARBURO DE TUNGSTENO TITANIUM USOS: EL INSTRUMENTAL KREBS FUE DESARROLLADO PARA USO EN CIRUGIA GENERAL, TRAUMATOLOGIA Y ORTOPEDIA, GINECOLOGIA, NEUROCIRUGIA, CIRUGIA PLASTICA, UROLOGIA, CIRUGIA MAXILLOFACIAL, OTORRINOLARINGOLOGIA, OFTALMOLOGIA ENTRE OTRAS. LAS CUALES PERMITEN HACER CORTE, DISECCION, TRACCION, MOVILIZACION Y COAGULACION DE LOS TEJIDOS PRESENTACIÓN COMERCIAL: UNIDAD OBSERVACIONES: EL PRESENTE REGISTRO SANITARIO AMPARA LAS SIGUIENTES REFERENCIAS: 01-2044 Tongue Depressing, Retractors bUCHWALD 180 mm 01-2045 Tongue Depressing, Retractors BRUENINGS 190 mm 01-2046 Tongue Depressing, Retractors FRENZEL 165 mm SIMPLEX Cheek and 01-2047 Tongue Depressing, Retractors Lip retractor 110 mm STRENBERG Cheek and Lip retractor 120 01-2048 Tongue Depressing, Retractors mm STRENBERG Cheek and Lip retractor 140 01-2049 Tongue Depressing, Retractors mm STRENBERG Cheek and Lip retractor 160 01-2050 Tongue Depressing, Retractors mm TOBOLD Tongue 01-2051 Tongue Depressing, Retractors depressor 145 mm ANDREW Tongue 01-2052 Tongue Depressing, Retractors depressor 110 mm WIEDER Tongue 01-2053 Tongue Depressing, Retractors depressor 140 mm WIEDER Tongue 01-2054 Tongue Depressing, Retractors depressor 150 mm SCHIMMELBUSCH 01-2055 Mouth Gags And Tongue Forceps Ether Mask 01-2056 Mouth Gags And Tongue Forceps HEISTER Mouth Gag Página 1 de 244 Información del Documento Original República de Colombia Ministerio de Salud y Protección Social Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA RESOLUCIÓN No. 2018051075 DE 23 de Noviembre de 2018 Por la cual se concede un Registro Sanitario El Director técnico de Dispositivos Médicos y otras Tecnologías del Instituto Nacional de Vigilancia de Medicamentos y Alimentos INVIMA, en ejercicio de las facultades Legales conferidas en el Decreto 2078 de 2012, decreto Reglamentario 4725 de 2005, ley 1437 de 2011 y ley 962 de 2005 130 mm FREGUSSON- ACKLAND Mouth Gag 01-2057 Mouth Gags And Tongue Forceps 145 mm DENHARDT Mouth Gag With Silicon Inserts, Interchangeable 125 01-2058 Mouth Gags And Tongue Forceps mm ROSER KOENIG 01-2059 Mouth Gags And Tongue Forceps Mouth Gag 160 mm ROSER KOENIG 01-2060 Mouth Gags And Tongue Forceps Mouth Gag 185 mm 01-2061 Mouth Gags And Tongue Forceps YOUNG 165 mm 01-2062 Mouth Gags And Tongue Forceps 1 Pair of Rubber Pads 01-2063 Mouth Gags And Tongue Forceps COLLIN 160 mm 01-2064 Mouth Gags And Tongue Forceps COLLIN 170 mm HEYWOOD-SMITH 01-2065 Mouth Gags And Tongue Forceps modif 215 mm MICHEL Rhinoscopic Mirrors With Interchangeable Mirror 01-2066 Blood Lancets & Laryngeal Mirrors Inserts 250 mm Spare Mirrors Only Ø 01-2067 Blood Lancets & Laryngeal Mirrors 12 mm Spare Mirrors Only Ø 01-2068 Blood Lancets & Laryngeal Mirrors 14 mm 01-2069 Blood Lancets & Laryngeal Mirrors Mirror Handle 110 mm 01-2070 Blood Lancets & Laryngeal Mirrors Mirror Handle 105 mm MAGILL Catheter Introducing Forceps - 01-2074 Diagnostc Sets Infants 150 mm MAGILL Catheter Introducing Forceps - 01-2075 Diagnostc Sets Children MAGILL Catheter Introducing Forceps - 01-2076 Diagnostc Sets Adults 250 mm Spare bulb 2.7 volt for 01-2078 Diagnostc Sets Otoscopes etc. With Metal Handle Fig 1 to 10 (Fig 1) 30mm 01-2101 Dissectng Knives 15cm 01-2102 Dissectng Knives Fig. 2 36mm 15cm 01-2103 Dissectng Knives Fig. 3 40mm 15.5cm 01-2104 Dissectng Knives Fig. 4 45 mm 16 cm 01-2105 Dissectng Knives Fig. 5 50 mm 16 cm 01-2106 Dissectng Knives Fig. 6 27 mm 15cm 01-2107 Dissectng Knives Fig. 7 35 mm 15cm 01-2108 Dissectng Knives Fig. 8 40mm 16cm 01-2109 Dissectng Knives Fig. 9 47mm 16cm 01-2110 Dissectng Knives Fig . 10 50mm 17cm Wooden Handle 01-2111 Autopsy & Cartlage Knives 255mm With wooden handle 01-2112 Autopsy & Cartlage Knives 210mm Página 2 de 244 Información del Documento Original República de Colombia Ministerio de Salud y Protección Social Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA RESOLUCIÓN No. 2018051075 DE 23 de Noviembre de 2018 Por la cual se concede un Registro Sanitario El Director técnico de Dispositivos Médicos y otras Tecnologías del Instituto Nacional de Vigilancia de Medicamentos y Alimentos INVIMA, en ejercicio de las facultades Legales conferidas en el Decreto 2078 de 2012, decreto Reglamentario 4725 de 2005, ley 1437 de 2011 y ley 962 de 2005 WALB with wooden 01-2113 Autopsy & Cartlage Knives handle 26cm 110mm WALB with wooden 01-2114 Autopsy & Cartlage Knives handle 29cm 140mm WALB with wooden 01-2115 Autopsy & Cartlage Knives handle 31cm 170mm VIRCHOW with hollow 01-2116 Autopsy & Cartlage Knives handle 26cm 160mm VIRCHOW with hollow 01-2117 Autopsy & Cartlage Knives handle 33.5cm 200mm VIRCHOW with hollow 01-2118 Autopsy & Cartlage Knives handle 38cm 240mm 01-2119 Scalpeles, Tenotomes & Resecton Knives GRAEFE 130mm 01-2120 Scalpeles, Tenotomes & Resecton Knives 01-2121 Scalpeles, Tenotomes & Resecton Knives 01-2122 Scalpeles, Tenotomes & Resecton Knives 01-2123 Scalpeles, Tenotomes & Resecton Knives 01-2124 Scalpeles, Tenotomes & Resecton Knives 01-2125 Scalpeles, Tenotomes & Resecton Knives DIEFENBACH 160mm 01-2126 Scalpeles, Tenotomes & Resecton Knives Tenotome 01-2127 Scalpeles, Tenotomes & Resecton Knives 290mm Langenbeck Length oh 01-2128 Scalpeles, Tenotomes & Resecton Knives Blade 55mm 180mm Langenbeck Length oh 01-2129 Scalpeles, Tenotomes & Resecton Knives Blade 55mm 190mm Tenotome 140mm - 01-2130 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2131 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2132 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2133 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2134 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2135 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2136 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2137 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2138 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2139 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2140 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2141 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2142 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2143 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2144 Scalpeles, Tenotomes 175mm 01-2145 Scalpeles, Tenotomes Tenotome 140mm - Página 3 de 244 Información del Documento Original República de Colombia Ministerio de Salud y Protección Social Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA RESOLUCIÓN No. 2018051075 DE 23 de Noviembre de 2018 Por la cual se concede un Registro Sanitario El Director técnico de Dispositivos Médicos y otras Tecnologías del Instituto Nacional de Vigilancia de Medicamentos y Alimentos INVIMA, en ejercicio de las facultades Legales conferidas en el Decreto 2078 de 2012, decreto Reglamentario 4725 de 2005, ley 1437 de 2011 y ley 962 de 2005 175mm Tenotome 140mm - 01-2146 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2147 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2148 Scalpeles, Tenotomes 175mm Tenotome 140mm - 01-2149 Scalpeles, Tenotomes 175mm Amputatng Knives, Cartlage Knives, Autopsy Kni LISTON Blade length Amputatng Knive 01-2150 130mm Amputatng Knives, Cartlage Knives, Autopsy 01-2151 Kni Blade length Amputatng Knive 130mm Amputatng Knives, Cartlage Knives, Autopsy 01-2152 Kni Blade length Amputatng Knive 190mm Amputatng Knives, Cartlage Knives, Autopsy 01-2153 Kni Blade length Amputatng Knive 220mm Amputatng Knives, Cartlage Knives, Autopsy Kni CALTLIN Blade length Amputatng Knive 01-2154 160mm Amputatng Knives, Cartlage Knives, Autopsy Kni Langenbeck Blade Length Flap Knives 01-2155 120mm Amputatng Knives, Cartlage Knives, Autopsy Kni Blade Length Interosseous Knives 01-2156 110mm Amputatng Knives, Cartlage Knives, Autopsy Kni Blade Length With Raspatory Wooden 01-2157 Handle 55mm Amputatng Knives, Cartlage Knives, Autopsy 01-2158 Kni Blade Length Wooden Handle 70mm Amputatng Knives, Cartlage Knives, Autopsy 01-2159 Kni Blade Length Metal Handle 80mm Amputatng Knives, Cartlage Knives, Autopsy 01-2160 Kni Blade Length Metal Handle 195mm Cone Knives, Myomatome,
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