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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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EP-TRACER 38 included in the cart system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
60SYS01
In Commercial Distribution

  • 04260441452615 ()


  • Cardiac electrophysiology analysis system
No Description
CardioTek B.V.
08ACC01
In Commercial Distribution

  • 04260441450574 ()


  • Cardiac electrophysiology analysis system
No Description
CardioTek B.V.
03UBC02
In Commercial Distribution

  • 04260441450482 ()


  • Cardiac electrophysiology analysis system
EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
40SYS02
In Commercial Distribution

  • 04260441455425 ()


  • Cardiac electrophysiology analysis system
EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
40SYS01
In Commercial Distribution

  • 04260441455418 ()


  • Cardiac electrophysiology analysis system
EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
32SYS02
In Commercial Distribution

  • 04260441455326 ()


  • Cardiac electrophysiology analysis system
No Description
MERGE HEALTHCARE SOLUTIONS INC.
RCSV2
In Commercial Distribution

  • 00842000101079 ()


  • Patient monitoring system module, multifunction
No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.4
In Commercial Distribution

  • 00842000100966 ()


  • Patient monitoring system module, multifunction
No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.3
In Commercial Distribution

  • 00842000100874 ()


  • Patient monitoring system module, multifunction
No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.2
In Commercial Distribution

  • 00842000100430 ()


  • Patient monitoring system module, multifunction
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