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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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Maestro™ Remote Control Cable -50' - 08714729774440

Remote Control Cable
BOSTON SCIENTIFIC CORPORATION
M004SVGA500
Not in Commercial Distribution

  • 08714729774440 ()
M004SVGA500

  • Electrical-only medical device connection cable, reusable

Maestro™ Remote Control Cable -25' - 08714729756811

Remote Control Cable
BOSTON SCIENTIFIC CORPORATION
M004SVGA250
Not in Commercial Distribution

  • 08714729756811 ()
M004SVGA250

  • Electrical-only medical device connection cable, reusable

Recording System EGM Cable - 08714729270010

Non-Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M004653S0
In Commercial Distribution

  • 08714729270010 ()


  • Electrical-only medical device connection cable, reusable

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

EnSite™ - 05415067047861

X EP System TactiFlex Ablation Cath, SE Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-03
In Commercial Distribution

  • 05415067047861 ()
ENSITE-TFM-03

  • Cardiac mapping system application software

EnSite™ - 05415067046659

X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution

  • 05415067046659 ()
ENSITE-TF-02

  • Cardiac mapping system application software

RHYTHMIA HDx™ - 00191506020798

Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA63020
In Commercial Distribution

  • 00191506020798 ()
M004RA63020

  • Cardiac mapping system

Henry Schein - 10304040180140

Pack Vein Ablation F/ AZ Vein and Laser Institute
HENRY SCHEIN, INC.
5703711
In Commercial Distribution

  • 00304040180143 ()
  • 10304040180140 ()
5703711

  • General surgical procedure kit, non-medicated, single-use

Ampere™ - 05415067013392

Fiber Cord Assembly Remote
ST. JUDE MEDICAL, INC.
H701339
In Commercial Distribution

  • 05415067013392 ()
H701339

  • Electrical-only medical device connection cable, reusable
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