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

  • 15420045513884 ()
CMP-01687

  • Microscope slide digital imaging scanner IVD
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
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
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
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
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
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
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
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500945 ()
71074-001

  • Laboratory instrument/analyser application software IVD
No Description
Stockert GmbH
S7014
In Commercial Distribution

  • 04260166370164 ()


  • Electrical catheter connection cable, reusable
Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
OTODYNAMICS LIMITED
NOVA-TABLET
In Commercial Distribution

  • 05060396171512 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.4
Not in Commercial Distribution

  • 00860271000945 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.3
Not in Commercial Distribution

  • 00860271000938 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.2
Not in Commercial Distribution

  • 00860271000921 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.1
Not in Commercial Distribution

  • 00860271000914 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.0
Not in Commercial Distribution

  • 00860271000907 ()


  • Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.4.0
In Commercial Distribution

  • 00860271000952 ()


  • Blood bank information system application software
No Description
NEUROLOGICA CORP.
10-00159-001
In Commercial Distribution

  • 10815411020212 ()


  • CT system workstation
Titanium single unit
Institut Straumann AG
Copings
In Commercial Distribution

  • 07630031728623 ()
010.2021

  • Custom-made dental crown, metal
No Description
Orthosoft Inc
20-8000-070-77
Not in Commercial Distribution

  • 00889024478978 ()
20-8000-070-77

  • Robotic surgical navigation system
No Description
Epocal Inc
HH-0003-XU-00
Not in Commercial Distribution

  • 00809708046514 ()


  • Metabolic profile clinical chemistry analyser IVD
Custom Abutment Ti, RN, incl. TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031717764 ()
040.689

  • Dental implant suprastructure, permanent, preformed
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.17
In Commercial Distribution

  • 00854344007764 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.16
In Commercial Distribution

  • 00854344007757 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.15
In Commercial Distribution

  • 00854344007740 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.14
In Commercial Distribution

  • 00854344007733 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.13
In Commercial Distribution

  • 00854344007726 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.12
In Commercial Distribution

  • 00854344007696 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.10
In Commercial Distribution

  • 00854344007672 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.6
In Commercial Distribution

  • 00854344007610 ()


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