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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™ - 05415067033482

Display Workstation Cart
ST. JUDE MEDICAL, INC.
ENSITE-DWSCART-01
In Commercial Distribution

  • 05415067033482 ()
ENSITE-DWSCART-01

  • Electromechanical device/system transport trolley

EnSite™ - 05415067033475

Dual Monitor Mount
ST. JUDE MEDICAL, INC.
ENSITE-DMMK-01
In Commercial Distribution

  • 05415067033475 ()
ENSITE-DMMK-01

  • Transportable medical equipment stand, non-powered

EnSite™ - 05415067033468

Recording System IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-CR-64-01
In Commercial Distribution

  • 05415067033468 ()
ENSITE-CR-64-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033451

Recording System IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-CR-56-01
In Commercial Distribution

  • 05415067033451 ()
ENSITE-CR-56-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033444

Catheter Input Module
ST. JUDE MEDICAL, INC.
ENSITE-CIM-80-01
In Commercial Distribution

  • 05415067033444 ()
ENSITE-CIM-80-01

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05415067033437

X EP System Catheter Input Module
ST. JUDE MEDICAL, INC.
ENSITE-CIM-20-01
In Commercial Distribution

  • 05415067033437 ()
ENSITE-CIM-20-01

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05415067033420

ECG Cable
ST. JUDE MEDICAL, INC.
ENSITE-CECG-60-01
In Commercial Distribution

  • 05415067033420 ()

  • Length: 152.0000 Centimeter
ENSITE-CECG-60-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033413

ECG Cable
ST. JUDE MEDICAL, INC.
ENSITE-CECG-144-01
In Commercial Distribution

  • 05415067033413 ()

  • Length: 366.0000 Centimeter
ENSITE-CECG-144-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033406

Amplifier Cart
ST. JUDE MEDICAL, INC.
ENSITE-AMPCART3-01
In Commercial Distribution

  • 05415067033406 ()
ENSITE-AMPCART3-01

  • Electromechanical device/system transport trolley

EnSite™ - 05415067033390

Amplifier Cart
ST. JUDE MEDICAL, INC.
ENSITE-AMPCART1-01
In Commercial Distribution

  • 05415067033390 ()
ENSITE-AMPCART1-01

  • Electromechanical device/system transport trolley

EnSite™ - 05415067033383

Connect Cable
ST. JUDE MEDICAL, INC.
ENSITE-ACBL-60-01
In Commercial Distribution

  • 05415067033383 ()

  • Length: 152.0000 Centimeter
ENSITE-ACBL-60-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033376

Connect Cable
ST. JUDE MEDICAL, INC.
ENSITE-ACBL-160-01
In Commercial Distribution

  • 05415067033376 ()

  • Length: 406.0000 Centimeter
ENSITE-ACBL-160-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033291

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

  • 05415067033291 ()
ENSITE-PRSBACK-01

  • Patient positioning sensor

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™ - 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™ - 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™ - 05415067031471

Software Installation
ST. JUDE MEDICAL, INC.
VL Mapping Catheter, Sensor Enabled
In Commercial Distribution

  • 05415067031471 ()
H702520

  • Electrical-only medical device connection adaptor, reusable

EnSite Precision™ - 05415067025265

Patient Reference Sensor
ST. JUDE MEDICAL, INC.
H702492
In Commercial Distribution

  • 05415067025265 ()
H702492

  • Patient positioning sensor

EnSite™ - 05415067024848

Noise Reduction Transformer, 120V
ST. JUDE MEDICAL, INC.
H702484
In Commercial Distribution

  • 05415067024848 ()
H702484

  • Constant-voltage transformer

EnSite Precision™ - 05415067024718

Field Frame Cable
ST. JUDE MEDICAL, INC.
H702471
In Commercial Distribution

  • 05415067024718 ()
H702471

  • Electrical-only medical device connection cable, reusable

EnSite Precision™ - 05415067024701

Module
ST. JUDE MEDICAL, INC.
H702470
In Commercial Distribution

  • 05415067024701 ()
H702470

  • Electromagnetic surgical navigation device tracking system

EnSite™ - 05415067053145

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-03
In Commercial Distribution

  • 05415067053145 ()
ENSITE-D-FWV-03

  • Cardiac mapping system application software
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