Devices

Decathlon Gold

  • Modèle / numéro de série
    All lot codes
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
  • Description du dispositif
    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

Fabricant

Spire Biomedical, Inc.
  • Adresse du fabricant
    Spire Biomedical, Inc., One Patriots Park, Bedford MA 01730-2343
  • Société-mère du fabricant (2017)
    Spire Corporation
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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Decathlon Gold Funnel
  • Modèle / numéro de série
    All lot codes
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
  • Description du dispositif
    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.