This document provides information about Plain Gut sutures. It describes Plain Gut as an absorbable, multifilament suture made of collagen from bovine intestines preserved in an isopropanol solution. It lists the manufacturer as Covidien and provides specifications such as presentation, storage conditions, sterilization method, references codes, and intended uses for closing soft tissues and ophthalmic surgery. The sutures are brown in color and absorb within 70 days with a tensile strength of 10 days.
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Plain Gut Suture Guide
1. FICHA TECNICA
PLAIN GUT
MULTIFILAMENTO ABSORBIBLE DE
ORIGEN NATURAL
LAT-CO-SI-0012-R0
Página 1 de 6
1. Información General
Producto (Según Registro Sanitario) Sutura Quirurgica Absorbible Chromic Gut, Mild
Chromic Gut, Plain Gut
Nombre Comercial Plain Gut Multifilamento Absorbible de Origen Natural
Marcas Covidien
Fabricante Legal Covidien LLC, USA
Número de Registro Sanitario INVIMA 2011DM-0000833-R1
Fecha de expiración del Registro Sanitario 18-Enero-2022
Clasificación del riesgo III
Código GMDN 13898
2. Especificaciones
Composición Acero Inoxidable, Colágeno, Solución de 89%
Isopropanol, 12 % agua, 1 % Trietanolamina
Presentación Comercial Caja por 1,2 y 3 Docenas
Condiciones de Almacenamiento Temperatura 20-25°C
Humedad relativa permanente Máximo 65%.
No debe exponerse a luz solar directa, ni luces
brillantes. Almacenarse en estibas de madera o
plástico a 10 cm del suelo.
Método de esterilización Rayos Gama
Vida Útil 5 Años
Referencias
2. FICHA TECNICA
PLAIN GUT
MULTIFILAMENTO ABSORBIBLE DE
ORIGEN NATURAL
LAT-CO-SI-0012-R0
Página 2 de 6
Referencia Descripción
CG172 Plain Gut Absorbable Suture
CG-172 Plain Gut Absorbable Suture
G205 Plain Gut Absorbable Suture
G-205 Plain Gut Absorbable Suture
SG751 Plain Gut Absorbable Suture
SG-751 Plain Gut Absorbable Suture
CG53 Plain Gut Absorbable Suture
CG-53 Plain Gut Absorbable Suture
G3 Plain Gut Absorbable Suture
G-3 Plain Gut Absorbable Suture
SG752 Plain Gut Absorbable Suture
SG-752 Plain Gut Absorbable Suture
CG62 Plain Gut Absorbable Suture
CG-62 Plain Gut Absorbable Suture
GG133 Plain Gut Absorbable Suture
GG-133 Plain Gut Absorbable Suture
SG810 Plain Gut Absorbable Suture
SG-810 Plain Gut Absorbable Suture
CG63 Plain Gut Absorbable Suture
CG-63 Plain Gut Absorbable Suture
GG321 Plain Gut Absorbable Suture
GG-321 Plain Gut Absorbable Suture
SG820 Plain Gut Absorbable Suture
SG-820 Plain Gut Absorbable Suture
CG842 Plain Gut Absorbable Suture
CG-842 Plain Gut Absorbable Suture
GG322 Plain Gut Absorbable Suture
GG-322 Plain Gut Absorbable Suture
SG820G Plain Gut Absorbable Suture
SG-820G Plain Gut Absorbable Suture
CG843 Plain Gut Absorbable Suture
CG-843 Plain Gut Absorbable Suture
3. FICHA TECNICA
PLAIN GUT
MULTIFILAMENTO ABSORBIBLE DE
ORIGEN NATURAL
LAT-CO-SI-0012-R0
Página 3 de 6
GG323 Plain Gut Absorbable Suture
GG-323 Plain Gut Absorbable Suture
SG821 Plain Gut Absorbable Suture
SG-821 Plain Gut Absorbable Suture
CG844 Plain Gut Absorbable Suture
CG-844 Plain Gut Absorbable Suture
LG101 Plain Gut Absorbable Suture
LG-101 Plain Gut Absorbable Suture
SG821G Plain Gut Absorbable Suture
SG-821G Plain Gut Absorbable Suture
CG845 Plain Gut Absorbable Suture
CG-845 Plain Gut Absorbable Suture
LG102 Plain Gut Absorbable Suture
LG-102 Plain Gut Absorbable Suture
SG822 Plain Gut Absorbable Suture
SG-822 Plain Gut Absorbable Suture
CG852 Plain Gut Absorbable Suture
CG-852 Plain Gut Absorbable Suture
LG103 Plain Gut Absorbable Suture
LG-103 Plain Gut Absorbable Suture
SG822G Plain Gut Absorbable Suture
SG-822G Plain Gut Absorbable Suture
CG853 Plain Gut Absorbable Suture
CG-853 Plain Gut Absorbable Suture
LG104 Plain Gut Absorbable Suture
LG-104 Plain Gut Absorbable Suture
SG823 Plain Gut Absorbable Suture
SG-823 Plain Gut Absorbable Suture
CG854 Plain Gut Absorbable Suture
CG-854 Plain Gut Absorbable Suture
SG1632G Plain Gut Absorbable Suture
SG-1632G Plain Gut Absorbable Suture
SG828 Plain Gut Absorbable Suture
4. FICHA TECNICA
PLAIN GUT
MULTIFILAMENTO ABSORBIBLE DE
ORIGEN NATURAL
LAT-CO-SI-0012-R0
Página 4 de 6
SG-828 Plain Gut Absorbable Suture
CG855 Plain Gut Absorbable Suture
CG-855 Plain Gut Absorbable Suture
SG1633G Plain Gut Absorbable Suture
SG-1633G Plain Gut Absorbable Suture
UG207 Plain Gut Absorbable Suture
UG-207 Plain Gut Absorbable Suture
CG872 Plain Gut Absorbable Suture
CG-872 Plain Gut Absorbable Suture
SG1645 Plain Gut Absorbable Suture
SG-1645 Plain Gut Absorbable Suture
UG862 Plain Gut Absorbable Suture
UG-862 Plain Gut Absorbable Suture
CG873 Plain Gut Absorbable Suture
CG-873 Plain Gut Absorbable Suture
SG1732G Plain Gut Absorbable Suture
SG-1732G Plain Gut Absorbable Suture
UG863 Plain Gut Absorbable Suture
UG-863 Plain Gut Absorbable Suture
G1735K Plain Gut Absorbable Suture
G-1735-K Plain Gut Absorbable Suture
SG5627 Plain Gut Absorbable Suture
SG-5627 Plain Gut Absorbable Suture
UG864 Plain Gut Absorbable Suture
UG-864 Plain Gut Absorbable Suture
G1770K Plain Gut Absorbable Suture
G-1770K Plain Gut Absorbable Suture
SG5627G Plain Gut Absorbable Suture
SG-5627G Plain Gut Absorbable Suture
UG878 Plain Gut Absorbable Suture
UG-878 Plain Gut Absorbable Suture
G1772K Plain Gut Absorbable Suture
G-1772K Plain Gut Absorbable Suture
5. FICHA TECNICA
PLAIN GUT
MULTIFILAMENTO ABSORBIBLE DE
ORIGEN NATURAL
LAT-CO-SI-0012-R0
Página 5 de 6
SG5630 Plain Gut Absorbable Suture
SG-5630 Plain Gut Absorbable Suture
G1773K Plain Gut Absorbable Suture
G-1773K Plain Gut Absorbable Suture
SG5630G Plain Gut Absorbable Suture
SG-5630G Plain Gut Absorbable Suture
G1774K Plain Gut Absorbable Suture
G-1774K Plain Gut Absorbable Suture
SG5654 Plain Gut Absorbable Suture
SG-5654 Plain Gut Absorbable Suture
G1775K Plain Gut Absorbable Suture
G-1775K Plain Gut Absorbable Suture
SG5654G Plain Gut Absorbable Suture
SG-5654G Plain Gut Absorbable Suture
G201 Plain Gut Absorbable Suture
G-201 Plain Gut Absorbable Suture
SG5686 Plain Gut Absorbable Suture
SG-5686 Plain Gut Absorbable Suture
G202 Plain Gut Absorbable Suture
G-202 Plain Gut Absorbable Suture
SG5696 Plain Gut Absorbable Suture
SG-5696 Plain Gut Absorbable Suture
G203 Plain Gut Absorbable Suture
G-203 Plain Gut Absorbable Suture
SG604 Plain Gut Absorbable Suture
SG-604 Plain Gut Absorbable Suture
G204 Plain Gut Absorbable Suture
G-204 Plain Gut Absorbable Suture
SG604G Plain Gut Absorbable Suture
SG-604G Plain Gut Absorbable Suture
SG612G Plain Gut Absorbable Suture
SG-612G Plain Gut Absorbable Suture
6. FICHA TECNICA
PLAIN GUT
MULTIFILAMENTO ABSORBIBLE DE
ORIGEN NATURAL
LAT-CO-SI-0012-R0
Página 6 de 6
3. Descripción del Producto
Indicaciones de Uso Aproximación y/o ligadura de tejido blandos. En
Cirugía Oftálmica.
DESCRIPCIÓN
Sutura Multifilamento Retorcido Absorbible de origen natural. Hecho de Colágeno (capa serosa)
Intestino Bovino y conservado e Hidratado en alcohol Isopropílico (89% solución de Isopropanol;
10% de agua y 1% Trietanolamina).
ESPECIFICACIONES TÉCNICAS
• Color Marrón
• Fuerza Tensil 10 Días
• Tiempo de Absorción 70 Días
• Calibres 0 al 4/0
NOTA: PARA LA CORRECTA UTILIZACION DEL DISPOSITIVO POR FAVOR LEER EL INSERTO
DEL PRODUCTO
Originado por:
Nombre: Martha L. Morales T.
Cargo: Assoc. Regulatory Affairs Specialist
Regulatory Affairs
Fecha:
04-Ago-17
Aprobado por:
Nombre: Juan Hariet Bolaños R.
Cargo: Sr. Regulatory Affairs Supervisor
Regulatory Affairs
Fecha:
04-Ago-17
Revisado por:
Nombre: Maria Mercedes D´leman
Cargo: Product Specialist Andean Region
Surgical Innovation
Fecha:
04-Ago-17