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 Focal Pear Catheter for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1033
In Commercial Distribution

  • 00854924006330 ()
FG-1033

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
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
ATHERECTOMY FG02550 CUTTERDRIVER UNI
MEDTRONIC, INC.
FG02550
In Commercial Distribution

  • 00643169968547 ()


  • Mechanical atherectomy system catheter, peripheral
Disposable IV Fluid / Blood Warmer unit
Mequ A/S
MWS201
In Commercial Distribution

  • 05700002076823 ()
  • 05700002076816 ()
MWS201

  • Conduction blood/fluid warmer
Single Use Sensor
EVENTUM ORTHOPAEDICS LTD
SE002
In Commercial Distribution

  • 05065012584493 ()


  • Arthroplasty force sensor
Single use sensor
EVENTUM ORTHOPAEDICS LTD
SE001
In Commercial Distribution

  • 05065012584158 ()


  • Arthroplasty force sensor
RePlay Hemostasis Clip, 18 mm
DIVERSATEK HEALTHCARE, INC.
1170-03
In Commercial Distribution

  • 10816734023171 ()
  • 00816734023174 ()
  • 20816734023178 ()
1170-03

  • Gastrointestinal endoscopic clip, short-term
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