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Preguntas frecuentes
Créditos
Devices
Alta Gold
Modelo / Serial
Al 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
55CM ALTA LR GOLD STD KIT || Model: ALC50SH55 || ALTA GOLD || 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr || dilator, 14Fr dilator, 16Fr valved 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.
1 Event
Retiro De Equipo (Recall) de Alta 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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Alta 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
40CM ALTA LR GOLD STD KIT || Model: ALC35SH40 || ALTA GOLD || 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr || dilator, 14Fr dilator, 16Fr valved 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
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