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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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Monarch™ Software Cart v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032750201020 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032740201050 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032740201040 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032740201030 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032740201020 ()


  • Robotic surgical system application software
IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD
Software Pristina 8.4 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.6
In Commercial Distribution

  • 00195278866899 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
Software Pristina 8.3 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.4
In Commercial Distribution

  • 00195278795724 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE
Medipixel
V1.0.0
In Commercial Distribution

  • 08800127400040 ()


  • Radiology DICOM image processing application software
KARL STORZ SCB Software Upgrade
Karl Storz GmbH & Co. KG
20090001-28
In Commercial Distribution

  • 04048551060599 ()


  • Operating room audiovisual data/device management system application software
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