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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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Analysis Client v2.2 - 00858637005857

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005857 ()


  • Laboratory instrument/analyser application software IVD

Analysis Server v2.2 - 00858637005840

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005840 ()


  • Laboratory instrument/analyser application software IVD

NOVIUS Lab - 00853023006159

Laboratory Information System application software
Cerner Corporation
27.2.2
Not in Commercial Distribution

  • 00853023006159 ()


  • Clinical laboratory information system application software

ClearPoint Array - 00850359007744

ClearPoint Array Software Version 1.0
Clearpoint Neuro, Inc.
CPA-SFW-11-1
In Commercial Distribution

  • 00850359007744 ()
CPA-SFW-11-1

  • Neurological stereotactic surgery system

ClearPoint Array - 00850376007871

ClearPoint Array Software Version 1.2
Clearpoint Neuro, Inc.
CPA-SFW-11-12
In Commercial Distribution

  • 00850376007871 ()
CPA-SFW-11-12

  • Neurological stereotactic surgery system

ClearPoint Array - 00850376007659

ClearPoint Array Software Version 1.1
Clearpoint Neuro, Inc.
CPA-SFW-11-11
In Commercial Distribution

  • 00850376007659 ()
CPA-SFW-11-11

  • Neurological stereotactic surgery system

SeeMore ViewBladder 10 Software - 00850921007134

SeeMore ViewBladder 10 Software 2.0.03
INTERSON CORP
2.0.03 ViewBladder
In Commercial Distribution

  • 00850921007134 ()
98-3518-00

  • Extracorporeal ultrasound imaging transducer, hand-held

Visix - 00851800007054

Visix 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007054 ()
Visix 8.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software

Visix - 00851800007047

Visix Pro software version 7.7.15
TELEVERE SYSTEMS, LLC
7.7.15
In Commercial Distribution

  • 00851800007047 ()
Visix Pro 7.7.15

  • Basic diagnostic x-ray system application software
  • Camera application software
  • General-purpose dental x-ray system application software
  • Radiological PACS software

TigerView - 00851800007023

TigerView Pro software version 7.7.3
TELEVERE SYSTEMS, LLC
7.7.3
In Commercial Distribution

  • 00851800007023 ()
TigerView Pro 7.7.3

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
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