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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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EnSite™ - 05415067033284

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

  • 05415067033284 ()
ENSITE-PRSFRNT-01

  • Patient positioning sensor

EnSite™ - 05415067033185

Software License
ST. JUDE MEDICAL, INC.
H702601
In Commercial Distribution

  • 05415067033185 ()
H702601

  • Cardiac mapping system application software

EnSite Precision™ - 05415067033178

System Software Upgrade
ST. JUDE MEDICAL, INC.
H702602
In Commercial Distribution

  • 05415067033178 ()
H702602

  • Cardiac mapping system application software

EnSite™ - 05415067032379

X EP System Surface Electrode Kit
ST. JUDE MEDICAL, INC.
ENSITE-SEK-5-01
In Commercial Distribution

  • 05415067032379 ()
  • 15415067032376 ()
ENSITE-SEK-5-01

  • Cardiac mapping system reference patch

EnSite Precision™ - 05415067032355

Surface Electrode Kit
ST. JUDE MEDICAL, INC.
PRCN-SEK-A
In Commercial Distribution

  • 05415067032355 ()
  • 15415067032352 ()
PRCN-SEK-A

  • Cardiac mapping system reference patch

EnSite™ - 05415067032300

Locating Electrodes
ST. JUDE MEDICAL, INC.
SURF-ELEC-2PRS
In Commercial Distribution

  • 05415067032300 ()
SURF-ELEC-2PRS

  • Cardiac mapping system reference patch

EnSite™ - 05415067032256

Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-CF-01
In Commercial Distribution

  • 05415067032256 ()
ENSITE-D-CF-01

  • Cardiac mapping system application software

EnSite™ - 05415067032249

Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-CF-01
In Commercial Distribution

  • 05415067032249 ()
ENSITE-CF-01

  • Cardiac mapping system application software

EnSite™ - 05415067032232

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

EnSite™ - 05415067032225

Field Frame Cable
ST. JUDE MEDICAL, INC.
ENSITE-FF-3MC-01
In Commercial Distribution

  • 05415067032225 ()
ENSITE-FF-3MC-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067032218

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

EnSite™ - 05415067032201

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

EnSite™ - 05415067032195

Field Frame
ST. JUDE MEDICAL, INC.
ENSITE-FF-01
In Commercial Distribution

  • 05415067032195 ()
ENSITE-FF-01

  • Electromagnetic surgical navigation device tracking system

EnSite™ - 05415067032188

Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-01
In Commercial Distribution

  • 05415067032188 ()
ENSITE-R-DWS-01

  • Cardiac mapping system

EnSite™ - 05415067032171

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

  • 05415067032171 ()
ENSITE-DWS-01

  • Cardiac mapping system

EnSite™ - 05415067032164

Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-01
In Commercial Distribution

  • 05415067032164 ()
ENSITE-R-AMP-01

  • Cardiac mapping system

EnSite™ - 05415067032157

Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-01
In Commercial Distribution

  • 05415067032157 ()
ENSITE-AMP-01

  • Cardiac mapping system

Advisor™ - 05415067030092

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
HD/VL Mapping Catheter
In Commercial Distribution

  • 05415067030092 ()
H702532

  • Electrical-only medical device connection adaptor, reusable

EnSite Precision™ - 05415067030085

Software Installation
ST. JUDE MEDICAL, INC.
H702469-SW
In Commercial Distribution

  • 05415067030085 ()
H702469-SW

  • Cardiac mapping system application software

EnSite™ - 05415067029799

Remote Monitor Stand
ST. JUDE MEDICAL, INC.
Velocity
In Commercial Distribution

  • 05415067029799 ()
H710003

  • Medical table clamp
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