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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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C2 CryoBalloon Ablation System - 00854924006255

Gen 2 360 Degree Pear Catheter
PENTAX OF AMERICA, INC.
FG-1025
In Commercial Distribution

  • 00854924006255 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

C2 CryoBalloon - 00854924006248

Pear Catheter Focal
C2 THERAPEUTICS, INC.
FG-1024
In Commercial Distribution

  • 00854924006248 ()
FG-1024

  • 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 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

Hydrofera Blue Ready - 00854827008813

Hydrofera Blue Ready TSD 3.5"x3.5"
HYDROFERA, LLC
HBRS3535E
In Commercial Distribution

  • 00854827008820 ()
  • 00854827008813 ()

  • Length: 3.5 Inch
  • Width: 3.5 Inch


  • Wound-nonadherent dressing, permeable, antimicrobial

Hydrofera Blue Ready Transfer - 00854827008790

Hydrofera Blue Ready Transfer 8"x8"
HYDROFERA, LLC
HBRT8080E
In Commercial Distribution

  • 00854827008806 ()
  • 00854827008790 ()

  • Length: 8 Inch
  • Width: 8 Inch


  • Wound-nonadherent dressing, permeable, antimicrobial

Hydrofera Blue Ready Transfer - 00854827008776

Hydrofera Blue Ready Transfer 4"x5"
HYDROFERA, LLC
HBRT4050E
In Commercial Distribution

  • 00854827008783 ()
  • 00854827008776 ()

  • Length: 4 Inch
  • Width: 5 Inch


  • Wound-nonadherent dressing, permeable, antimicrobial

Hydrofera Blue Ready Transfer - 00854827008752

Hydrofera Blue Ready Transfer 2.5"x2.5"
HYDROFERA, LLC
HBRT2525E
In Commercial Distribution

  • 00854827008769 ()
  • 00854827008752 ()

  • Length: 2.5 Inch
  • Width: 2.5 Inch


  • Wound-nonadherent dressing, permeable, antimicrobial

Hydrofera Blue Ready - 00854827008738

Hydrofera Blue Ready 8"x8"
HYDROFERA, LLC
HBRS8820E
In Commercial Distribution

  • 00854827008745 ()
  • 00854827008738 ()

  • Length: 8 Inch
  • Width: 8 Inch


  • Wound-nonadherent dressing, permeable, antimicrobial
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