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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™ - 05415067034748

X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-02
In Commercial Distribution

  • 05415067034748 ()
ENSITE-R-AMP-02

  • Cardiac mapping system

EnSite™ - 05415067033789

Recording System Connector
ST. JUDE MEDICAL, INC.
100019308
In Commercial Distribution

  • 05415067033789 ()
100019308

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05415067033673

IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-WM64-60-01
In Commercial Distribution

  • 05415067033673 ()

  • Length: 152.0000 Centimeter
ENSITE-WM64-60-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033666

IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-WM64-144-01
In Commercial Distribution

  • 05415067033666 ()

  • Length: 366.0000 Centimeter
ENSITE-WM64-144-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033659

IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-WM56-60-01
In Commercial Distribution

  • 05415067033659 ()

  • Length: 152.0000 Centimeter
ENSITE-WM56-60-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033642

IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-WM56-144-01
In Commercial Distribution

  • 05415067033642 ()

  • Length: 366.0000 Centimeter
ENSITE-WM56-144-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033635

Triple Monitor Mount
ST. JUDE MEDICAL, INC.
ENSITE-TMMK-01
In Commercial Distribution

  • 05415067033635 ()
ENSITE-TMMK-01

  • Transportable medical equipment stand, non-powered

EnSite™ - 05415067033611

X EP System SurfaceLink module
ST. JUDE MEDICAL, INC.
ENSITE-SRFLNK-01
In Commercial Distribution

  • 05415067033611 ()
ENSITE-SRFLNK-01

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05415067033604

Single Monitor Mount
ST. JUDE MEDICAL, INC.
ENSITE-SMMK-01
In Commercial Distribution

  • 05415067033604 ()
ENSITE-SMMK-01

  • Transportable medical equipment stand, non-powered

EnSite™ - 05415067033598

Remote Monitor Stand
ST. JUDE MEDICAL, INC.
ENSITE-RMS-01
In Commercial Distribution

  • 05415067033598 ()
ENSITE-RMS-01

  • Transportable medical equipment stand, non-powered

EnSite™ - 05415067033581

Bedrail Mount
ST. JUDE MEDICAL, INC.
ENSITE-RAILMNT-01
In Commercial Distribution

  • 05415067033581 ()
ENSITE-RAILMNT-01

  • Portable active medical device mount

EnSite™ - 05415067033574

Monitor Pole
ST. JUDE MEDICAL, INC.
ENSITE-MONPOLE-01
In Commercial Distribution

  • 05415067033574 ()
ENSITE-MONPOLE-01

  • Transportable medical equipment stand, non-powered

EnSite™ - 05415067033567

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

  • 05415067033567 ()
ENSITE-FF-BRCKT-01

  • Medical table clamp

EnSite™ - 05415067033550

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

  • 05415067033550 ()
ENSITE-FF-ABRKT-01

  • Medical table clamp

EnSite™ - 05415067033536

Radio-opaque ECG Lead Set
ST. JUDE MEDICAL, INC.
ENSITE-ECGRO-01
In Commercial Distribution

  • 05415067033536 ()

  • Length: 152.0000 Centimeter
ENSITE-ECGRO-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033512

Radio-lucent ECG Lead Set
ST. JUDE MEDICAL, INC.
ENSITE-ECGRL-01
In Commercial Distribution

  • 05415067033512 ()

  • Length: 152.0000 Centimeter
ENSITE-ECGRL-01

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067033499

X EP System ECG Output Module
ST. JUDE MEDICAL, INC.
ENSITE-ECGOUT-01
In Commercial Distribution

  • 05415067033499 ()
ENSITE-ECGOUT-01

  • Electrical-only medical device connection adaptor, reusable

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™ - 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™ - 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™ - 05415067031402

System Reference Electrode
ST. JUDE MEDICAL, INC.
SYS-REF-V1
In Commercial Distribution

  • 05415067031402 ()
SYS-REF-V1

  • Cardiac mapping system reference patch

EnSite Precision™ - 05415067030382

Adjustable Field Frame Bracket
ST. JUDE MEDICAL, INC.
H702533
In Commercial Distribution

  • 05415067030382 ()
H702533

  • Medical table clamp
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