Devices

Alta Gold

  • Model / Serial
    All lot codes
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
  • Product Description
    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.
  • 5 Events

Manufacturer

Spire Biomedical, Inc.
  • Manufacturer Address
    Spire Biomedical, Inc., One Patriots Park, Bedford MA 01730-2343
  • Manufacturer Parent Company (2017)
    Spire Corporation
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Alta Gold
  • Model / Serial
    Al lot codes
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
  • Product Description
    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.