Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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C2 CryoBalloon Full 8 Catheter for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1032
In Commercial Distribution

  • 00854924006323 ()
FG-1032

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
C2 CryoBalloon Swipe Catheter with Standard Balloon for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1015
In Commercial Distribution

  • 00854924006156 ()
FG-1015

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
C2 CryoBalloon Focal Catheter with Standard Balloon for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1009
In Commercial Distribution

  • 00854924006095 ()
FG-1009

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
C2 CryoBalloon Full Catheter with Standard Balloon for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1008
In Commercial Distribution

  • 00854924006088 ()
FG-1008

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact handheld disposable surgical instrument. It enables a surgeon to provide fluid suction, bipolar cautery and CO2 laser energy delivered via a flexible OmniGuide fiber for minimally invasive surgery. The handpiece is delivered sterile, and is intended for one-time use only. TRIO has been validated to be used with the Valleylab Triad or Valleylab Force FX.
OMNIGUIDE, INC.
1
In Commercial Distribution

  • 00852306007708 ()
323000

  • Electrosurgical handpiece, single-use
ATHERECTOMY FG02550 CUTTERDRIVER UNI
MEDTRONIC, INC.
FG02550
In Commercial Distribution

  • 00643169968547 ()


  • Mechanical atherectomy system catheter, peripheral
The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool. The instrument is an accessory to the Fiagon navigation system. It is designed to be used with the Fiagon Navigation system and with XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool. The XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by Entellus Medical Inc./USA and are registered as 510K devices with the FDA. These are not subject of this instructions for use.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0139131 ()

  • Length: 278 Millimeter
  • Outer Diameter: 0.6 Millimeter


  • Multi-purpose stereotactic surgery system
The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-400-00
In Commercial Distribution

  • B815SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-300-00
In Commercial Distribution

  • B815SA300000 ()
SA-300-00

  • Haemodialysis blood tubing set, single-use
The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
DI-400-00
In Commercial Distribution

  • B815DI400000 ()
DI-400-00

  • Haemodialysis blood tubing set, single-use
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