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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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Thinprep Imaging System - 15420045508163

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045508163 ()
ASY-11145

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504042

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045504042 ()
ASY-08388

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501041

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045501041 ()
ASY-06030

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501034

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
Not in Commercial Distribution

  • 15420045501034 ()
ASY-03446

  • Laboratory instrument/analyser application software IVD

WAVELIGHT ALLEGRO TOPOLYZER - 00380659907678

WAVELIGHT TOPOLYZER VARIO: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990767
In Commercial Distribution

  • 00380659907678 ()

  • Weight: 70.4 Pound


  • Corneal topography system

WAVELIGHT REFRACTIVE SUITE - 00380659906060

ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990606
Not in Commercial Distribution

  • 00380659906060 ()

  • Weight: 188 Pound


  • Corneal topography system

Cervista HTA System - 15420045501065

No Description
Hologic, Inc.
Cervista HTA System Computer
Not in Commercial Distribution

  • 15420045501065 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

Cervista Manual System - 15420045501058

No Description
Hologic, Inc.
Cervista Manual System Computer
Not in Commercial Distribution

  • 15420045501058 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

Alcon - 00380659909498

Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software

ACRYSOF® IQ RESTOR® - 00380659909481

AcrySof IQ ReSTOR Multifocal Toric IOL +2.5 D IOL Calculator
Alcon Laboratories, Inc.
Version 1
In Commercial Distribution

  • 00380659909481 ()


  • Intraocular lens calculation software
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