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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 - 15420045517097

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

  • 15420045517097 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045512511

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

  • 15420045512511 ()
CMP-01667

  • Laboratory instrument/analyser application software IVD

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

DIGITAL DIAGNOSTICS SYSTEM - 15420045513884

Computer to operate the Genius™ Digital Imager.
Hologic, Inc.
COMPUTER, DIGITAL IMAGER
In Commercial Distribution

  • 15420045513884 ()
CMP-01687

  • Microscope slide digital imaging scanner 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

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

ThinPrep Imaging System - 15420045504035

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

  • 15420045504035 ()
CMP-01284

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500990

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

  • 15420045500990 ()
CMP-00815

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500983

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

  • 15420045500983 ()
71278-001

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500976

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

  • 15420045500976 ()
71964-001

  • Laboratory instrument/analyser application software IVD
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