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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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cobas® Liat® Strep A Script - 07613336129692

No Description
Roche Molecular Systems, Inc.
08085471001
In Commercial Distribution

  • 07613336129692 ()
08085471001

  • Laboratory instrument/analyser application software IVD

cobas® Liat® Influenza A/B Script - 07613336129685

No Description
Roche Molecular Systems, Inc.
08085463001
In Commercial Distribution

  • 07613336129685 ()
08085463001

  • Laboratory instrument/analyser application software IVD

Clear Guide ONE - B201CGONE0

No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution

  • B201CGONE1 ()
  • B201CGONE0 ()


  • Ultrasound imaging system application software

Connected OR OS - 07613327311846

No Description
STRYKER CORPORATION
0240060145
In Commercial Distribution

  • 07613327311846 ()
0240-060-145

  • Operating room audiovisual data/device management system application software

Connect OR OS - 07613327311839

No Description
STRYKER CORPORATION
0240060140
In Commercial Distribution

  • 07613327311839 ()
0240-060-140

  • Operating room audiovisual data/device management system application software

EDM LITE KIT - 00809708114572

No Description
Epocal Inc
SD-0004-00-00
Not in Commercial Distribution

  • 00809708114572 ()


  • Laboratory instrument/analyser application software IVD

HemoCue® 801 Connect - 07311091391681

HemoCue® 801 Connect
Hemocue AB
139168
Not in Commercial Distribution

  • 07311091391681 ()
139168

  • Laboratory instrument/analyser application software IVD

DI Remote Review Software version 6.x.x - 07350040975930

The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
AG516335
In Commercial Distribution

  • 07350040975930 ()
AG516335

  • Laboratory instrument/analyser application software IVD

CellaVision® Remote Review Software, Enterprise Edition, version independent - 07350040975923

The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-EN0099
In Commercial Distribution

  • 07350040975923 ()
CRRS-GR0099

  • Laboratory instrument/analyser application software IVD

CellaVision® Remote Review Software, Group Edition, version independent - 07350040975916

The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-GR0099
In Commercial Distribution

  • 07350040975916 ()
CRRS-GR0099

  • Laboratory instrument/analyser application software IVD
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