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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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No Description
Biosense Webster Inc
CG2025CT
In Commercial Distribution

  • 10846835003826 ()
CG2025CT

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CB3434CT
In Commercial Distribution

  • 10846835003802 ()
CB3434CT

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CB3412CT
In Commercial Distribution

  • 10846835003796 ()
CB3412CT

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CB3410CT
In Commercial Distribution

  • 10846835003789 ()
CB3410CT

  • Electrical-only medical device connection cable, reusable
CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution

  • 10846835000870 ()
FG-5400-00

  • Cardiac mapping system
CAM 14
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
14
In Commercial Distribution

  • 00840682110075 ()


  • Electrocardiograph, professional, single-channel
CV WEB 3.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
3
Not in Commercial Distribution

  • 00840682107921 ()


  • Cardiology information system application software
MUSE V9
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v9
In Commercial Distribution

  • 00840682100182 ()


  • Cardiology information system application software
MARS V8
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V8
Not in Commercial Distribution

  • 00840682100069 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE SPECIALSLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123587 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE COMBOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123570 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE INW SERVER V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123563 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE MAC-LAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123556 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE CARDIOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123549 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SOFTWARE GE CLIENT SOFTWARE V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123532 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
ASSY, CARDIOLAB SIMULATOR GE INT USE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Simulator-Internal
Not in Commercial Distribution

  • 00840682119689 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
ASSY PDM BASE STATION PLUS CO2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Plus
In Commercial Distribution

  • 00840682119665 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
ASSY, CARDIOLAB SIMULATOR
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Simulator
Not in Commercial Distribution

  • 00840682119641 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
Upgrade Kit MLCL V7.1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
BT21
Not in Commercial Distribution

  • 00840682188968 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
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