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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Mobile Next Upgrade Kit
ST. JUDE MEDICAL, INC.
1014934
In Commercial Distribution

  • 05415067036742 ()
1014934

  • Coronary optical coherence tomography system
OPTISi Next Monitor
ST. JUDE MEDICAL, INC.
1014942
In Commercial Distribution

  • 05415067036728 ()
1014942

  • Coronary optical coherence tomography system
OPTISi Next DOC
ST. JUDE MEDICAL, INC.
1014940
In Commercial Distribution

  • 05415067036704 ()
1014940

  • Coronary optical coherence tomography system
Triple Monitor Mount
ST. JUDE MEDICAL, INC.
ENSITE-TMMK-01
In Commercial Distribution

  • 05415067033635 ()
ENSITE-TMMK-01

  • Transportable medical equipment stand, non-powered
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
Single Monitor Mount
ST. JUDE MEDICAL, INC.
ENSITE-SMMK-01
In Commercial Distribution

  • 05415067033604 ()
ENSITE-SMMK-01

  • Transportable medical equipment stand, non-powered
Remote Monitor Stand
ST. JUDE MEDICAL, INC.
ENSITE-RMS-01
In Commercial Distribution

  • 05415067033598 ()
ENSITE-RMS-01

  • Transportable medical equipment stand, non-powered
Bedrail Mount
ST. JUDE MEDICAL, INC.
ENSITE-RAILMNT-01
In Commercial Distribution

  • 05415067033581 ()
ENSITE-RAILMNT-01

  • Portable active medical device mount
Monitor Pole
ST. JUDE MEDICAL, INC.
ENSITE-MONPOLE-01
In Commercial Distribution

  • 05415067033574 ()
ENSITE-MONPOLE-01

  • Transportable medical equipment stand, non-powered
Fixed Field Frame Bracket
ST. JUDE MEDICAL, INC.
ENSITE-FF-BRCKT-01
In Commercial Distribution

  • 05415067033567 ()
ENSITE-FF-BRCKT-01

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

  • 05415067033550 ()
ENSITE-FF-ABRKT-01

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

  • 05415067033482 ()
ENSITE-DWSCART-01

  • Electromechanical device/system transport trolley
Dual Monitor Mount
ST. JUDE MEDICAL, INC.
ENSITE-DMMK-01
In Commercial Distribution

  • 05415067033475 ()
ENSITE-DMMK-01

  • Transportable medical equipment stand, non-powered
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
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
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
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
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
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
Amplifier Cart
ST. JUDE MEDICAL, INC.
ENSITE-AMPCART3-01
In Commercial Distribution

  • 05415067033406 ()
ENSITE-AMPCART3-01

  • Electromechanical device/system transport trolley
Amplifier Cart
ST. JUDE MEDICAL, INC.
ENSITE-AMPCART1-01
In Commercial Distribution

  • 05415067033390 ()
ENSITE-AMPCART1-01

  • Electromechanical device/system transport trolley
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
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
Delivery Sheath
ST. JUDE MEDICAL, INC.
9-TDS-09F45-80
In Commercial Distribution

  • 05415067033369 ()

  • Length: 80.0000 Centimeter
  • Catheter Gauge: 9.0000 French
9-TDS-09F45-80

  • Cardiac occluder delivery kit
Delivery Sheath
ST. JUDE MEDICAL, INC.
9-TDS-08F45-80
In Commercial Distribution

  • 05415067033352 ()

  • Length: 80.0000 Centimeter
  • Catheter Gauge: 8.0000 French
9-TDS-08F45-80

  • Cardiac occluder delivery kit
PFO Occluder
ST. JUDE MEDICAL, INC.
9-PFO-3525
In Commercial Distribution

  • 05415067033345 ()

  • Catheter Gauge: 9.0000 French
  • Outer Diameter: 35.0000 Millimeter
9-PFO-3525

  • Cardiac defect occluder
PFO Occluder
ST. JUDE MEDICAL, INC.
9-PFO-3025
In Commercial Distribution

  • 05415067033321 ()

  • Outer Diameter: 30.0000 Millimeter
  • Catheter Gauge: 9.0000 French
9-PFO-3025

  • Cardiac defect occluder
PFO Occluder
ST. JUDE MEDICAL, INC.
9-PFO-2518
In Commercial Distribution

  • 05415067033314 ()

  • Catheter Gauge: 8.0000 French
  • Outer Diameter: 25.0000 Millimeter
9-PFO-2518

  • Cardiac defect occluder
PFO Occluder
ST. JUDE MEDICAL, INC.
9-PFO-1818
In Commercial Distribution

  • 05415067033307 ()

  • Outer Diameter: 18.0000 Millimeter
  • Catheter Gauge: 8.0000 French
9-PFO-1818

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

  • 05415067033291 ()
ENSITE-PRSBACK-01

  • Patient positioning sensor
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
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-27
In Commercial Distribution

  • 05415067033154 ()
ESP200-27

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-25
In Commercial Distribution

  • 05415067033147 ()
ESP200-25

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-23
In Commercial Distribution

  • 05415067033130 ()
ESP200-23

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-21
In Commercial Distribution

  • 05415067033123 ()
ESP200-21

  • Aortic open-surgery heart valve bioprosthesis
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