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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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DIGITAL DIAGNOSTICS SYSTEM - 15420045513914

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045513914 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

Thinprep Imaging System - 15420045513716

Computer to operate the ThinPrep® Integrated Imager.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045513716 ()
CMP-01764

  • Laboratory instrument/analyser application software IVD

LENS CONNECTED TOWER APPLICATION - 00885556778777

LENS CONNECTED TOWER APPLICATION
Smith & Nephew, Inc.
72205347
In Commercial Distribution

  • 00885556778777 ()
72205347

  • Operating room audiovisual data/device management system application software

INTEllIO LINK WEREWOLF - 00885556741641

INTELLIO LINK WEREWOLF
Smith & Nephew, Inc.
72205191
In Commercial Distribution

  • 00885556741641 ()
72205191

  • Operating room audiovisual data/device management system application software

LINK DOUBLEFLOW PUMP - 00885556741634

LINK DOUBLEFLO PUMP
Smith & Nephew, Inc.
72205190
In Commercial Distribution

  • 00885556741634 ()
72205190

  • Operating room audiovisual data/device management system application software

INTELLIO LINK Dyonics Power II - 00885556741627

INTELLIO LINK DYONICS POWER II
Smith & Nephew, Inc.
72205189
In Commercial Distribution

  • 00885556741627 ()
72205189

  • Operating room audiovisual data/device management system application software

ThinPrep Imaging System - 15420045508040

Automated cytology review microscope with ThinPrep® slide imaging functionality.
Hologic, Inc.
ThinPrep Imaging System Review Scope
In Commercial Distribution

  • 15420045508040 ()
ASY-07233

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507258

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507258 ()
CMP-01515

  • Laboratory instrument/analyser application software IVD

PRIMA - 15420045504691

Prima
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD

MULTIVIEW - 15420045504684

MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis.
Hologic, Inc.
MultiView
In Commercial Distribution

  • 15420045504684 ()
SFW-03541

  • Laboratory instrument/analyser application software IVD
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