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SUTURA SURGILON

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SUTURA SINTÉTICA NO ABSORBIBLE

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SUTURA SURGILON

  1. 1. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 1 de 10 1. Información General Producto (Según Registro Sanitario) Surgilon Braided Nylon Nonabsorbable Suture / Nylon Trenzado Surgilon Nombre Comercial Surgilon Sutura sintética no absorbible Marcas Surgilon, Covidien, Medtronic Fabricante Legal Medtronic INC, USA Número de Registro Sanitario INVIMA 2017DM-0000205-R2 Fecha de expiración del Registro Sanitario 16-Enero- 2027 Clasificación del riesgo III Código GMDN 37997 2. Especificaciones Composición Nylon Presentación Comercial Unidad, Caja x 1,2 y 3 Docenas Condiciones de Almacenamiento Temperatura: 20-25C Humedad relativa permanente: Máximo 65% No exponerse a la luz solar directa, ni luces brillantes. Almacenarse en estibas de madera o plástico a 10cm del suelo. El producto debe ser conservado en su envase original, en ambiente fresco, lejos de la luz solar directa, del polvo y la humedad. El área debe estar libre de goteras y de entrada de gases contaminantes. Método de esterilización Óxido De Etileno Vida Útil 5 Años Referencias
  2. 2. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 2 de 10 Referencia Descripción 8886191782 Surgilon™ Braided Nylon 88861917-82 Surgilon™ Braided Nylon 8886192923 Surgilon™ Braided Nylon 88861929-23 Surgilon™ Braided Nylon 8886198551 Surgilon™ Braided Nylon 88861985-51 Surgilon™ Braided Nylon 8886188351 Surgilon™ Braided Nylon 88861883-51 Surgilon™ Braided Nylon 8886192933 Surgilon™ Braided Nylon 88861929-33 Surgilon™ Braided Nylon 8886198561 Surgilon™ Braided Nylon 88861985-61 Surgilon™ Braided Nylon 8886188361 Surgilon™ Braided Nylon 88861883-61 Surgilon™ Braided Nylon 8886193133 Surgilon™ Braided Nylon 88861931-33 Surgilon™ Braided Nylon 8886198571 Surgilon™ Braided Nylon 88861985-71 Surgilon™ Braided Nylon 8886188351 Surgilon™ Braided Nylon 88861883-51 Surgilon™ Braided Nylon 8886193143 Surgilon™ Braided Nylon 88861931-43 Surgilon™ Braided Nylon 8886198842 Surgilon™ Braided Nylon 88861988-42 Surgilon™ Braided Nylon 8886188371 Surgilon™ Braided Nylon 88861883-71 Surgilon™ Braided Nylon 8886193251 Surgilon™ Braided Nylon 88861932-51 Surgilon™ Braided Nylon 8886198932 Surgilon™ Braided Nylon 88861989-32 Surgilon™ Braided Nylon 8886189571 Surgilon™ Braided Nylon 88861895-71 Surgilon™ Braided Nylon
  3. 3. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 3 de 10 8886193331 Surgilon™ Braided Nylon 88861933-31 Surgilon™ Braided Nylon 8886198942 Surgilon™ Braided Nylon 88861989-42 Surgilon™ Braided Nylon 8886189941 Surgilon™ Braided Nylon 88861899-41 Surgilon™ Braided Nylon 8886193443 Surgilon™ Braided Nylon 88861934-43 Surgilon™ Braided Nylon 8886199352 Surgilon™ Braided Nylon 88861993-52 Surgilon™ Braided Nylon 8886189951 Surgilon™ Braided Nylon 88861899-51 Surgilon™ Braided Nylon 8886193453 Surgilon™ Braided Nylon 88861934-53 Surgilon™ Braided Nylon 8886199362 Surgilon™ Braided Nylon 88861993-62 Surgilon™ Braided Nylon 8886190261 Surgilon™ Braided Nylon 88861902-61 Surgilon™ Braided Nylon 8886193541 Surgilon™ Braided Nylon 88861935-41 Surgilon™ Braided Nylon 8886199531 Surgilon™ Braided Nylon 88861995-31 Surgilon™ Braided Nylon 8886190271 Surgilon™ Braided Nylon 88861902-71 Surgilon™ Braided Nylon 8886193551 Surgilon™ Braided Nylon 88861935-51 Surgilon™ Braided Nylon 8886199541 Surgilon™ Braided Nylon 88861995-41 Surgilon™ Braided Nylon 8886190642 Surgilon™ Braided Nylon 88861906-42 Surgilon™ Braided Nylon 8886193561 Surgilon™ Braided Nylon 88861935-61 Surgilon™ Braided Nylon 8886199732 Surgilon™ Braided Nylon 88861997-32 Surgilon™ Braided Nylon
  4. 4. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 4 de 10 8886190652 Surgilon™ Braided Nylon 88861906-52 Surgilon™ Braided Nylon 8886193652 Surgilon™ Braided Nylon 88861936-52 Surgilon™ Braided Nylon 8886199862 Surgilon™ Braided Nylon 88861998-62 Surgilon™ Braided Nylon 8886190962 Surgilon™ Braided Nylon 88861909-62 Surgilon™ Braided Nylon 8886193662 Surgilon™ Braided Nylon 88861936-62 Surgilon™ Braided Nylon 8886199872 Surgilon™ Braided Nylon 88861998-72 Surgilon™ Braided Nylon 8886191022 Surgilon™ Braided Nylon 88861910-22 Surgilon™ Braided Nylon 8886193951 Surgilon™ Braided Nylon 88861939-51 Surgilon™ Braided Nylon 8886201151 Surgilon™ Braided Nylon 88862011-51 Surgilon™ Braided Nylon 8886191032 Surgilon™ Braided Nylon 88861910-32 Surgilon™ Braided Nylon 8886194161 Surgilon™ Braided Nylon 88861941-61 Surgilon™ Braided Nylon 8886211032 Surgilon™ Braided Nylon 88862110-32 Surgilon™ Braided Nylon 8886191251 Surgilon™ Braided Nylon 88861912-51 Surgilon™ Braided Nylon 8886194171 Surgilon™ Braided Nylon 88861941-71 Surgilon™ Braided Nylon 8886195332J Surgilon™ Braided Nylon 88861953-32J Surgilon™ Braided Nylon 8886191261 Surgilon™ Braided Nylon 88861912-61 Surgilon™ Braided Nylon 8886194471 Surgilon™ Braided Nylon 88861944-71 Surgilon™ Braided Nylon
  5. 5. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 5 de 10 8886195432J Surgilon™ Braided Nylon 88861954-32J Surgilon™ Braided Nylon 8886191271 Surgilon™ Braided Nylon 88861912-71 Surgilon™ Braided Nylon 8886194851 Surgilon™ Braided Nylon 88861948-51 Surgilon™ Braided Nylon 8886199032J Surgilon™ Braided Nylon 88861990-32J Surgilon™ Braided Nylon 8886191372 Surgilon™ Braided Nylon 88861913-72 Surgilon™ Braided Nylon 8886194861 Surgilon™ Braided Nylon 88861948-61 Surgilon™ Braided Nylon 8886199042J Surgilon™ Braided Nylon 88861990-42J Surgilon™ Braided Nylon 8886191453 Surgilon™ Braided Nylon 88861914-53 Surgilon™ Braided Nylon 8886194881 Surgilon™ Braided Nylon 88861948-81 Surgilon™ Braided Nylon BS2333K Surgilon™ Braided Nylon BS2333K Surgilon™ Braided Nylon 8886191473 Surgilon™ Braided Nylon 88861914-73 Surgilon™ Braided Nylon 8886195141 Surgilon™ Braided Nylon 88861951-41 Surgilon™ Braided Nylon SBS5881G Surgilon™ Braided Nylon SBS-5881G Surgilon™ Braided Nylon 8886191483 Surgilon™ Braided Nylon 88861914-83 Surgilon™ Braided Nylon 8886195151 Surgilon™ Braided Nylon 88861951-51 Surgilon™ Braided Nylon CBST851MG Surgilon™ Braided Nylon CBST-851-MG Surgilon™ Braided Nylon 8886191551 Surgilon™ Braided Nylon 88861915-51 Surgilon™ Braided Nylon
  6. 6. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 6 de 10 8886195161 Surgilon™ Braided Nylon 88861951-61 Surgilon™ Braided Nylon SBS1880G Surgilon™ Braided Nylon SBS-1880G Surgilon™ Braided Nylon 8886191561 Surgilon™ Braided Nylon 88861915-61 Surgilon™ Braided Nylon 8886195171 Surgilon™ Braided Nylon 88861951-71 Surgilon™ Braided Nylon SBS1883G Surgilon™ Braided Nylon SBS-1883G Surgilon™ Braided Nylon 8886191571 Surgilon™ Braided Nylon 88861915-71 Surgilon™ Braided Nylon 8886195261 Surgilon™ Braided Nylon 88861952-61 Surgilon™ Braided Nylon SBS1884G Surgilon™ Braided Nylon SBS-1884G Surgilon™ Braided Nylon 8886191641 Surgilon™ Braided Nylon 88861916-41 Surgilon™ Braided Nylon 8886195732 Surgilon™ Braided Nylon 88861957-32 Surgilon™ Braided Nylon SBS1928G Surgilon™ Braided Nylon SBS-1928G Surgilon™ Braided Nylon 8886191761 Surgilon™ Braided Nylon 88861917-61 Surgilon™ Braided Nylon 8886195832 Surgilon™ Braided Nylon 88861958-32 Surgilon™ Braided Nylon SBS1938G Surgilon™ Braided Nylon SBS-1938G Surgilon™ Braided Nylon 8886191771 Surgilon™ Braided Nylon 88861917-71 Surgilon™ Braided Nylon 8886195842 Surgilon™ Braided Nylon 88861958-42 Surgilon™ Braided Nylon SBS1940G Surgilon™ Braided Nylon SBS-1940G Surgilon™ Braided Nylon
  7. 7. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 7 de 10 8886191782 Surgilon™ Braided Nylon 88861917-82 Surgilon™ Braided Nylon 8886195852 Surgilon™ Braided Nylon 88861958-52 Surgilon™ Braided Nylon SBS566G Surgilon™ Braided Nylon SBS-566G Surgilon™ Braided Nylon 8886191831 Surgilon™ Braided Nylon 88861918-31 Surgilon™ Braided Nylon 8886196252 Surgilon™ Braided Nylon 88861962-52 Surgilon™ Braided Nylon SBS570M Surgilon™ Braided Nylon SBS-570-M Surgilon™ Braided Nylon 8886191841 Surgilon™ Braided Nylon 88861918-41 Surgilon™ Braided Nylon 8886196262 Surgilon™ Braided Nylon 88861962-62 Surgilon™ Braided Nylon 8886196952 Surgilon™ Braided Nylon 88861969-52 Surgilon™ Braided Nylon 8886191851 Surgilon™ Braided Nylon 88861918-51 Surgilon™ Braided Nylon 8886196272 Surgilon™ Braided Nylon 88861962-72 Surgilon™ Braided Nylon 8886196962 Surgilon™ Braided Nylon 88861969-62 Surgilon™ Braided Nylon 8886191931 Surgilon™ Braided Nylon 88861919-31 Surgilon™ Braided Nylon 8886196441 Surgilon™ Braided Nylon 88861964-41 Surgilon™ Braided Nylon 8886196972 Surgilon™ Braided Nylon 88861969-72 Surgilon™ Braided Nylon 8886191941 Surgilon™ Braided Nylon 88861919-41 Surgilon™ Braided Nylon 8886196451 Surgilon™ Braided Nylon 88861964-51 Surgilon™ Braided Nylon
  8. 8. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 8 de 10 8886197161 Surgilon™ Braided Nylon 88861971-61 Surgilon™ Braided Nylon 8886191951 Surgilon™ Braided Nylon 88861919-51 Surgilon™ Braided Nylon 8886196461 Surgilon™ Braided Nylon 88861964-61 Surgilon™ Braided Nylon 8886197171 Surgilon™ Braided Nylon 88861971-71 Surgilon™ Braided Nylon 8886191961 Surgilon™ Braided Nylon 88861919-61 Surgilon™ Braided Nylon 8886196471 Surgilon™ Braided Nylon 88861964-71 Surgilon™ Braided Nylon 8886198133 Surgilon™ Braided Nylon 88861981-33 Surgilon™ Braided Nylon 8886191971 Surgilon™ Braided Nylon 88861919-71 Surgilon™ Braided Nylon 8886196752 Surgilon™ Braided Nylon 88861967-52 Surgilon™ Braided Nylon 8886198241 Surgilon™ Braided Nylon 88861982-41 Surgilon™ Braided Nylon 8886192052 Surgilon™ Braided Nylon 88861920-52 Surgilon™ Braided Nylon 8886196851 Surgilon™ Braided Nylon 88861968-51 Surgilon™ Braided Nylon 8886198251 Surgilon™ Braided Nylon 88861982-51 Surgilon™ Braided Nylon 8886192062 Surgilon™ Braided Nylon 88861920-62 Surgilon™ Braided Nylon 8886196861 Surgilon™ Braided Nylon 88861968-61 Surgilon™ Braided Nylon 8886198342 Surgilon™ Braided Nylon 88861983-42 Surgilon™ Braided Nylon 8886192732 Surgilon™ Braided Nylon 88861927-32 Surgilon™ Braided Nylon
  9. 9. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 9 de 10 8886192072 Surgilon™ Braided Nylon 88861920-72 Surgilon™ Braided Nylon 8886198352 Surgilon™ Braided Nylon 88861983-52 Surgilon™ Braided Nylon 8886192742 Surgilon™ Braided Nylon 88861927-42 Surgilon™ Braided Nylon 8886192093 Surgilon™ Braided Nylon 88861920-93 Surgilon™ Braided Nylon 8886198452 Surgilon™ Braided Nylon 88861984-52 Surgilon™ Braided Nylon 8886192852 Surgilon™ Braided Nylon 88861928-52 Surgilon™ Braided Nylon 8886192271 Surgilon™ Braided Nylon 88861922-71 Surgilon™ Braided Nylon 8886192862 Surgilon™ Braided Nylon 88861928-62 Surgilon™ Braided Nylon 8886192642 Surgilon™ Braided Nylon 88861926-42 Surgilon™ Braided Nylon 8886192872 Surgilon™ Braided Nylon 88861928-72 Surgilon™ Braided Nylon 8886192652 Surgilon™ Braided Nylon 88861926-52 Surgilon™ Braided Nylon 3. Descripción del Producto Indicaciones de Uso Están indicadas para para la aproximación y/o ligaduras de tejidos blandos en general, inclusive en cirugía cardiovascular, oftalmológica y neurocirugía. DESCRIPCIÓN El producto presenta las siguientes características: • Es una sutura inerte por lo cual genera mínima reacción tisular • Brinda un paso fácil y suave por el tejido. • Memoria y enrollamiento mínimos. • Estructura: Multifilamento No Absorbible
  10. 10. FICHA TECNICA SURGILON SUTURA SINTETICA NO ABSORBIBLE LAT-CO-SI-0013-R0 Página 10 de 10 • Componente: Polímeros Alifáticos de la Cadena Poliamida • Color: Negro • Fuerza Tensil: Indefinida • Calibres: 2/0 Al 4/ 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

SUTURA SINTÉTICA NO ABSORBIBLE

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