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Créditos
Devices
Decathlon Gold
Modelo / Serial
All lot codes
Clasificación del producto
Gastroenterology-Urology Devices
Clase de dispositivo
2
¿Implante?
Yes
Distribución
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Descripción del producto
32CM DECATHLON GOLD STD KIT || Models: DEC27SH32 and DEC27SH32-K || DECATHLON GOLD || 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic || hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr || dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.
3 Events
Retiro De Equipo (Recall) de Decathlon Gold
Retiro De Equipo (Recall) de Decathlon Gold
Retiro De Equipo (Recall) de Decathlon Gold
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Fabricante
Spire Biomedical, Inc.
Dirección del fabricante
Spire Biomedical, Inc., One Patriots Park, Bedford MA 01730-2343
Empresa matriz del fabricante (2017)
Spire Corporation
Source
USFDA
Dispositivo con un nombre similar
Más información acerca de la data
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Decathlon Gold Funnel
Modelo / Serial
All lot codes
Clasificación del producto
Gastroenterology-Urology Devices
Clase de dispositivo
2
¿Implante?
Yes
Distribución
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Descripción del producto
28CM DECATHLON GOLD FUNNEL TIP STD KIT || Models: DFC23SH28 and DFC23SH28-K || DECATHLON GOLD FUNNEL TIP || 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic || hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch || guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.
Language
English
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