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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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N/A - 00643169071957

COMPUTER 945NWCPU DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPU
In Commercial Distribution

  • 00643169071957 ()


  • Nerve-locating system

ARVIS ® - 00810180350624

ARVIS Computer Module
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-12700
In Commercial Distribution

  • 00810180350624 ()


  • Orthopaedic stereotactic surgery system

Tablet computer holder - 07640176970962

Tablet computer holder
Naviswiss AG
NS096
In Commercial Distribution

  • 07640176970962 ()


  • Optical surgical navigation device tracking system

iTero Mobile Computing Unit - 00816063020844

Scanner computer unit
Align Technology, Inc.
211386
In Commercial Distribution

  • 00816063020844 ()


  • Dental milling system, CAD/CAM, chairside

iTero Computing Unit - 00816063020837

Scanner computer unit
Align Technology, Inc.
211385
In Commercial Distribution

  • 00816063020837 ()


  • Dental milling system, CAD/CAM, chairside

LessRay - 00887517948199

LessRay Computer Set
Nuvasive, Inc.
LRCPUMKT
In Commercial Distribution

  • 00887517948199 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517790521

LessRay Computer Set
Nuvasive, Inc.
LRCPULOAN
In Commercial Distribution

  • 00887517790521 ()


  • Neurophysiologic monitoring system

Navio - 00885556628478

Navio Computer Cart
Smith & Nephew, Inc.
PFSR110002
In Commercial Distribution

  • 00885556628478 ()
PFSR110002

  • Robotic surgical arm system

LessRay - 00887517732699

LessRay Computer Enclosure
Nuvasive, Inc.
8230004
In Commercial Distribution

  • 00887517732699 ()


  • Diagnostic x-ray digital imaging system workstation

NIM-ECLIPSE® - 00763000102388

COMPUTER 945NCCPUE4 LAPTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000102388 ()


  • Portable computer

NIM-Eclipse® - 00763000102371

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000102371 ()


  • Nerve-locating system

NIM-Eclipse - 00763000570279

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000570279 ()


  • Nerve-locating system

NIM-Eclipse - 00763000570262

COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000570262 ()


  • Portable computer

NIM-Eclipse - 00763000384197

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000384197 ()


  • Nerve-locating system

NIM-Eclipse - 00763000384180

COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000384180 ()


  • Portable computer

Iradimed - 00856038001201

MRI Monitor Remote Tablet
IRADIMED CORP.
3885T
In Commercial Distribution

  • 00856038001201 ()
3885T

  • Portable computer

ImmersiveTouch - B940IVZBKIT0

ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
IMMERSIVETOUCH, INC.
ImmersiveTouch4
In Commercial Distribution

  • B940IVZBKIT0 ()


  • Portable computer

AIM™ System - 00840094456099

No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer

AIM™ System - 00840094456082

No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer

AIM™ System - 00840094454668

No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer

AIM™ System - 00840094454651

No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer

n.a. - 04048551009864

Optical Mouse
Karl Storz GmbH & Co. KG
40800028
In Commercial Distribution

  • 04048551009864 ()


  • Computer terminal

PT Vicinity IT Workstation - 04048675053682

No Description
Drägerwerk AG & Co. KGaA
MS17277
Not in Commercial Distribution

  • 04048675053682 ()


  • Desktop computer

IMAGE1 PILOT - 04048551387337

IMAGE1 PILOT
Karl Storz GmbH & Co. KG
TC014
In Commercial Distribution

  • 04048551387337 ()


  • Desktop computer

Vmax - 10846446026443

OPTIPLEX XE2 WIN7 64BIT ENGLISH 100_240V (VMAX)
Carefusion Corporation
26751-307
Not in Commercial Distribution

  • 10846446026443 ()
26751-307

  • Desktop computer

Somnostar - 10846446033298

SOMNOSTAR 11 UPGRADE
Carefusion Corporation
29675-001
Not in Commercial Distribution

  • 10846446033298 ()
29675-001

  • Desktop computer

superDimension - 10884521582835

Planning Station
Covidien LP
AED00170-01
In Commercial Distribution

  • 10884521582835 ()


  • Portable computer

superDimension - 10884521545588

Planning Station
Covidien LP
AED00172-30
In Commercial Distribution

  • 10884521545588 ()


  • Portable computer

ARIAL - 00840948103025

Chromebook for Arial Web Client Only
Securitas Healthcare LLC
54385
In Commercial Distribution

  • 00840948103025 ()
54385

  • Desktop computer

ARIAL - 00840948103018

Arial Web App Configured Tower.
Securitas Healthcare LLC
0850-173
In Commercial Distribution

  • 00840948103018 ()
0850-173

  • Desktop computer
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