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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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PASCAL Synthesis - 00855005006010

(577) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577
In Commercial Distribution

  • 00855005006010 ()
SA-06281

  • Ophthalmic solid-state laser system, photodisruption

PASCAL Synthesis - 00855005006003

(532) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532
In Commercial Distribution

  • 00855005006003 ()
SA-06280

  • Ophthalmic solid-state laser system, photodisruption

C2 CryoBalloon Focal Pear Catheter - 00854924006330

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 - 00854924006323

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, Standard - 00854924006156

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 Cartridge, Large - 00854924006132

C2 CryoBalloon Cartridge for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1013
In Commercial Distribution

  • 00854924006132 ()
FG-1013

  • High-pressure medical gas hose

C2 CryoBalloon Focal Controller - 00854924006125

C2 CryoBalloon Focal Controller for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1012
In Commercial Distribution

  • 00854924006125 ()
FG-1012

  • High-pressure medical gas hose
  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

C2 CryoBalloon Cartridge, Regular - 00854924006101

C2 CryoBalloon Cartridge, Regular, for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1010
In Commercial Distribution

  • 00854924006101 ()
FG-1010

  • High-pressure medical gas hose

C2 CryoBalloon Focal Catheter, Standard - 00854924006095

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

Catheter, Full, Standard - 00854924006088

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
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