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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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BIS - 10884521533103

BISX4 Module
Covidien LP
186-0224-USF
In Commercial Distribution

  • 10884521533103 ()


  • Anaesthesia depth monitor

BIS - 10884521533097

BISX4 Module Software Version 1.15
Covidien LP
186-0224-SF
In Commercial Distribution

  • 10884521533097 ()


  • Anaesthesia depth monitor

BIS - 10884521533080

BISX4 Module
Covidien LP
186-0224-SLM
In Commercial Distribution

  • 10884521533080 ()


  • Anaesthesia depth monitor

BIS - 10884521533073

BISX4 Module Software Version 1.15; For use with Nihon Kohden Monitors
Covidien LP
186-0224-NK
In Commercial Distribution

  • 10884521533073 ()


  • Anaesthesia depth monitor

BIS - 10884521533066

BISX4 Module
Covidien LP
186-0224-UPH
In Commercial Distribution

  • 10884521533066 ()


  • Anaesthesia depth monitor

BIS - 10884521533059

BISX4 Module Software Version 1.15. For use with Philips Patient Monitors
Covidien LP
186-0224-PH
In Commercial Distribution

  • 10884521533059 ()


  • Anaesthesia depth monitor

BIS - 90884521657515

Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 90884521657515 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor

BIS - 20884521134505

Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 20884521134505 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor

NA - 04546540505712

FLUOROSCOPY SOFTWARE 2.3
Stryker Leibinger GmbH & Co. KG
6004-650-000
In Commercial Distribution

  • 04546540505712 ()
6004-650-000

  • Robotic surgical navigation system application software

AlignRT Plus - 05056190500320

AlignRT 6.1 software
VISION RT LIMITED
AlignRT 6.1
Not in Commercial Distribution

  • 05056190500320 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500177

AlignRT 6.0 software
VISION RT LIMITED
AlignRT 6.0
Not in Commercial Distribution

  • 05056190500177 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500818

AlignRT 6.2 software
VISION RT LIMITED
AlignRT 6.2
Not in Commercial Distribution

  • 05056190500818 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500689

AlignRT 6.3 software
VISION RT LIMITED
AlignRT 6.3
In Commercial Distribution

  • 05056190500689 ()


  • Radiological video camera patient positioning/tracking system

SureSmile Advanced Software - 00856379007108

SureSmile Advanced Software
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007108 ()
DIGI-500159

  • CAD/CAM software

SureSmile Ortho Software - 00856379007092

SureSmile Ortho Software
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007092 ()
DIGI-500153

  • CAD/CAM software

REMI Robotic Navigation System - 00850026574364

Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software

EP-WorkMate™ - 05415067003560

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

  • 05415067003560 ()
100043247

  • Cardiac catheterization monitoring system

SPRINT - 00850022775291

Clinical Programmer Software
SPR THERAPEUTICS, INC.
50009
In Commercial Distribution

  • 00850022775291 ()
50009

  • Analgesic PENS system

VNS Therapy™ Programmer, Model 3100 v1.1.0 - 05425025750634

Programmer and Software
LIVANOVA USA, INC.
3100
In Commercial Distribution

  • 05425025750634 ()


  • Vagus nerve electrical stimulation system programmer

WorkMate Claris™ - 05415067042385

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800014
In Commercial Distribution

  • 05415067042385 ()
H800014

  • Cardiac catheterization monitoring system

WorkMate™ Scribe™ - 05415067042361

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800015
In Commercial Distribution

  • 05415067042361 ()
H800015

  • Cardiac catheterization monitoring system

AptiVue™ - 05415067030856

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
1014666
In Commercial Distribution

  • 05415067030856 ()
1014666

  • Coronary optical coherence tomography system

AptiVue™ - 05415067030108

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
1014661
In Commercial Distribution

  • 05415067030108 ()
1014661

  • Cardiac catheterization laboratory computer
  • Coronary optical coherence tomography system

QUANTIEN™ - 05415067030009

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

  • 05415067030009 ()
H1014680

  • Cardiac catheterization laboratory computer

Quantien™ - 05415067029997

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

  • 05415067029997 ()
H1014670

  • Cardiac catheterization laboratory computer

MediGuide™ - 05415067023711

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

  • 05415067023711 ()
MG1000

  • Cardiac mapping system

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

WorkMate Claris™ - 05415067020185

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

  • 05415067020185 ()
H702018

  • Cardiac catheterization monitoring system
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