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 Class Implantable

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X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-01
In Commercial Distribution

  • 05415067032171 ()
ENSITE-DWS-01

  • Cardiac mapping system
Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-01
In Commercial Distribution

  • 05415067032164 ()
ENSITE-R-AMP-01

  • Cardiac mapping system
Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-01
In Commercial Distribution

  • 05415067032157 ()
ENSITE-AMP-01

  • Cardiac mapping system
AcQMap System
ACUTUS MEDICAL, INC.
900000
Not in Commercial Distribution

  • 00857042007999 ()
900000

  • Cardiac mapping system
AcQMap System Console 2.0
ACUTUS MEDICAL, INC.
900100
Not in Commercial Distribution

  • 00857042007920 ()
900100

  • Cardiac mapping system
AcQMap Ablation Reference Cable
ACUTUS MEDICAL, INC.
800505
Not in Commercial Distribution

  • 00857042007326 ()
800505

  • Cardiac mapping system
AcQMap Ablation Electrogram Cable
ACUTUS MEDICAL, INC.
800508
Not in Commercial Distribution

  • 00857042007319 ()
800508

  • Cardiac mapping system
AcQMap Auxiliary Interface Box
ACUTUS MEDICAL, INC.
800422
Not in Commercial Distribution

  • 00857042007302 ()
800422

  • Cardiac mapping system
AcQMap Console
ACUTUS MEDICAL, INC.
800500
Not in Commercial Distribution

  • 00857042007296 ()
800500

  • Cardiac mapping system
AcQMap Workstation
ACUTUS MEDICAL, INC.
800520
Not in Commercial Distribution

  • 00857042007289 ()
800520

  • Cardiac mapping system
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