REF GEM2753FC (2.5mm)

  • Model / Serial
    SP15H05-1067842 thru SP15KI9-1099303
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
  • Product Description
    GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. || Product Usage: || The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
  • Source
    USFDA