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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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Isansys - 05060488680182

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T580 - 10.1 - WiFi
In Commercial Distribution

  • 05060488680182 ()
Gateway T580 - 10.1 - WiFi

  • Physiological measuring device wireless data capture/transfer unit

ThinPrep Imaging System - 15420045504103

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

  • 15420045504103 ()
ASY-08346

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504097

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

  • 15420045504097 ()
ASY-06281

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504080

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

  • 15420045504080 ()
ASY-06284

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045512535

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

  • 15420045512535 ()
ASY-13755

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507265

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

  • 15420045507265 ()
ASY-10745

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045515062

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

  • 15420045515062 ()
CMP-01836

  • Laboratory instrument/analyser application software IVD

Nyquist.IQ - 00853901007032

Digital Medical Image Processor
OMEGA MEDICAL IMAGING, LLC
IPS-100
In Commercial Distribution

  • 00853901007032 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging Software, Nexus DR, v4.17 - 00854344007764

No Description
VAREX IMAGING CORPORATION
Nexus DR v4.17
In Commercial Distribution

  • 00854344007764 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging Software, Nexus DR, v4.16 - 00854344007757

No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.16
In Commercial Distribution

  • 00854344007757 ()


  • X-ray system computer, diagnostic, general-purpose
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