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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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Patient Reference Sensor
ST. JUDE MEDICAL, INC.
ENSITE-PRSFRNT-01
In Commercial Distribution

  • 05415067033284 ()
ENSITE-PRSFRNT-01

  • Patient positioning sensor
Software License
ST. JUDE MEDICAL, INC.
H702601
In Commercial Distribution

  • 05415067033185 ()
H702601

  • Cardiac mapping system application software
System Software Upgrade
ST. JUDE MEDICAL, INC.
H702602
In Commercial Distribution

  • 05415067033178 ()
H702602

  • Cardiac mapping system application software
Field Frame Cable
ST. JUDE MEDICAL, INC.
ENSITE-FF-4.5C-01
In Commercial Distribution

  • 05415067032232 ()
ENSITE-FF-4.5C-01

  • Electrical-only medical device connection cable, reusable
Amplifier Power Module
ST. JUDE MEDICAL, INC.
ENSITE-AMP-EPM-01
In Commercial Distribution

  • 05415067032218 ()
ENSITE-AMP-EPM-01

  • Electrical-only medical device connection cable, reusable
X EP System Field Frame
ST. JUDE MEDICAL, INC.
ENSITE-R-FF-01
In Commercial Distribution

  • 05415067032201 ()
ENSITE-R-FF-01

  • Electromagnetic surgical navigation device tracking system
Field Frame
ST. JUDE MEDICAL, INC.
ENSITE-FF-01
In Commercial Distribution

  • 05415067032195 ()
ENSITE-FF-01

  • Electromagnetic surgical navigation device tracking system
Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-01
In Commercial Distribution

  • 05415067032188 ()
ENSITE-R-DWS-01

  • Cardiac mapping system
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
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