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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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MediGuide™ - 05415067027085

System
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067027085 ()
MG1000

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026316

Bedrail Mount Kit
ST. JUDE MEDICAL, INC.
H702474
In Commercial Distribution

  • 05415067026316 ()
H702474

  • Medical device storage mount

EnSite Precision™ - 05415067026309

Power Supply Kit
ST. JUDE MEDICAL, INC.
H702505
In Commercial Distribution

  • 05415067026309 ()
H702505

  • Electrical-only medical device connection cable, reusable

EnSite™ Verismo™ - 05415067026293

Software Upgrade Kit, v.2.0.1
ST. JUDE MEDICAL, INC.
H702504
In Commercial Distribution

  • 05415067026293 ()
H702504

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026279

Software Installation, v.1.0.1
ST. JUDE MEDICAL, INC.
H702503
In Commercial Distribution

  • 05415067026279 ()
H702503

  • Cardiac mapping system application software

FlexAbility™ Ablation Catheter, Sensor Enabled™ - 05415067026248

Software Installation
ST. JUDE MEDICAL, INC.
H702509
In Commercial Distribution

  • 05415067026248 ()
H702509

  • Cardiac mapping system application software

Advisor™ FL Mapping Catheter, Sensor Enabled™ - 05415067026231

Software Installation
ST. JUDE MEDICAL, INC.
H702507
In Commercial Distribution

  • 05415067026231 ()
H702507

  • Electrical-only medical device connection adaptor, reusable

EnSite™ Fusion™ - 05415067026224

Software Upgrade Kit, v.7.1
ST. JUDE MEDICAL, INC.
H702506
In Commercial Distribution

  • 05415067026224 ()
H702506

  • Cardiac mapping system application software

EnSite™ Derexi™ - 05415067026217

Module, v.1.3.1
ST. JUDE MEDICAL, INC.
H702502
In Commercial Distribution

  • 05415067026217 ()
H702502

  • Cardiac mapping system application software

EnSite™ - 05415067026200

Software Upgrade Kit, 30 day license, v.2.0
ST. JUDE MEDICAL, INC.
Contact Force Module
In Commercial Distribution

  • 05415067026200 ()
H702500-T

  • Cardiac mapping system application software

EnSite™ - 05415067026194

Software Upgrade Kit, v.2.0
ST. JUDE MEDICAL, INC.
Contact Force Module
In Commercial Distribution

  • 05415067026194 ()
H702500

  • Cardiac mapping system application software

EnSite™ Courier™ - 05415067026187

Software Installation, 30 day trial, v.3.0
ST. JUDE MEDICAL, INC.
H702501-T
In Commercial Distribution

  • 05415067026187 ()
H702501-T

  • Cardiac mapping system application software

EnSite™ Courier™ - 05415067026170

Software Installation, v.3.0
ST. JUDE MEDICAL, INC.
H702501
In Commercial Distribution

  • 05415067026170 ()
H702501

  • Cardiac mapping system application software

EnSite™ - 05415067026163

Module, 30 day trial, v.1.0
ST. JUDE MEDICAL, INC.
AutoMap
In Commercial Distribution

  • 05415067026163 ()
H702498-T

  • Cardiac mapping system application software

AutoMark - 05415067026149

Software Installation, v.1.0
ST. JUDE MEDICAL, INC.
H702499
In Commercial Distribution

  • 05415067026149 ()
H702499

  • Cardiac mapping system application software

EnSite™ - 05415067026132

Module, v.1.0
ST. JUDE MEDICAL, INC.
AutoMap
In Commercial Distribution

  • 05415067026132 ()
H702498

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026125

Software Installation, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496
In Commercial Distribution

  • 05415067026125 ()
H702496

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026118

Software Installation, 30 day trial, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496-T
In Commercial Distribution

  • 05415067026118 ()
H702496-T

  • Cardiac mapping system application software

EnSite™ Velocity™ - 05415067026101

Software Upgrade Kit, v.5.0.2
ST. JUDE MEDICAL, INC.
H702495
In Commercial Distribution

  • 05415067026101 ()
H702495

  • Cardiac mapping system application software

EnSite Precision™ - 05415067025937

Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0020-P
In Commercial Distribution

  • 05415067025937 ()
EN0020-P

  • Cardiac mapping system reference patch

EnSite Precision™ - 05415067025265

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

  • 05415067025265 ()
H702492

  • Patient positioning sensor

EnSite™ - 05415067024909

Noise Reduction Transformer, 100V
ST. JUDE MEDICAL, INC.
H702490
In Commercial Distribution

  • 05415067024909 ()
H702490

  • Constant-voltage transformer

EnSite™ - 05415067024848

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

  • 05415067024848 ()
H702484

  • Constant-voltage transformer

EnSite™ - 05415067024831

Noise Reduction Transformer, 240V
ST. JUDE MEDICAL, INC.
H702483
In Commercial Distribution

  • 05415067024831 ()
H702483

  • Constant-voltage transformer

EnSite Precision™ - 05415067024756

Link Sensor Enabled Link
ST. JUDE MEDICAL, INC.
H702475
In Commercial Distribution

  • 05415067024756 ()
H702475

  • Electromagnetic surgical navigation device tracking system

EnSite Precision™ - 05415067024732

Module
ST. JUDE MEDICAL, INC.
H702473
In Commercial Distribution

  • 05415067024732 ()
H702473

  • Electromagnetic surgical navigation device tracking system

EnSite Precision™ - 05415067024725

Field Frame Bracket
ST. JUDE MEDICAL, INC.
H702472
In Commercial Distribution

  • 05415067024725 ()
H702472

  • Medical table clamp

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 Precision™ - 05415067024695

Field Frame
ST. JUDE MEDICAL, INC.
H702469
In Commercial Distribution

  • 05415067024695 ()
H702469

  • Electromagnetic surgical navigation device tracking system

MediGuide™ - 05415067024275

Cath Connect, Sensor Enabled
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067024275 ()
H702427

  • Cardiac mapping system application software

MediGuide™ - 05415067023841

System Installation Tool
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067023841 ()
H702371

  • Cardiac mapping system application software

MediGuide™ - 05415067023711

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067023711 ()
MG1000

  • Cardiac mapping system

EnSite™ Velocity™ - 05415067023230

Utility Upgrade Kit
ST. JUDE MEDICAL, INC.
H702323
In Commercial Distribution

  • 05415067023230 ()
H702323

  • Cardiac mapping system application software

WorkMate™ Scribe™ - 05415067023223

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Module
In Commercial Distribution

  • 05415067023223 ()
H702322

  • Cardiac catheterization monitoring system

WorkMate™ Unity™ - 05415067023216

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Module
In Commercial Distribution

  • 05415067023216 ()
H702321

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067023209

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

  • 05415067023209 ()

  • Height: 8.5 Inch
  • Depth: 16.8 Inch
  • Width: 16.8 Inch
  • Weight: 33.4 Pound
H702320

  • Cardiac catheterization monitoring system

MediGuide™ - 05415067020512

VD10 Compatible System
ST. JUDE MEDICAL, INC.
MG1000
In Commercial Distribution

  • 05415067020512 ()
MG1000

  • Cardiac mapping system

MediGuide™ - 05415067020475

System
ST. JUDE MEDICAL, INC.
MG1000
In Commercial Distribution

  • 05415067020475 ()
MG1000

  • Cardiac mapping system

MediGuide™ - 05415067020468

System
ST. JUDE MEDICAL, INC.
MG1000
In Commercial Distribution

  • 05415067020468 ()
MG1000

  • Cardiac mapping system
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