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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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PAV+ SOFTWARE, FINISHED GOOD, FACTORY INSTALL
Covidien LP
10122271
Not in Commercial Distribution

  • 10884521641013 ()


  • Ventilator application software
Win 11 PC - Arial Software Client
Securitas Healthcare LLC
0850-222
In Commercial Distribution

  • 00840948102738 ()
0850-222

  • Fixed call button
Siemens UNITY 3 SOFTWARE (USB STICK)
Ws Audiology Usa, Inc.
UNITY 3 SOFTWARE (USB STICK)
Not in Commercial Distribution

  • 04046355641976 ()
10823966

  • Audiometric/hearing aid tester
Software Pristina ME 9.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA ME 9.2
In Commercial Distribution

  • 00195278719812 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software
PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only
PULSE Software Package including IOM, iG
Nuvasive, Inc.
8000104
In Commercial Distribution

  • 00195377099013 ()


  • Orthopaedic stereotactic surgery system
Knee Software Package, ART 2.0.1 Add-on
Omni Life Science, Inc.
NS-27007
In Commercial Distribution

  • 00841690194538 ()
NS-27007

  • Instrument tray, reusable
Knee Software Package, ART 2.1 Add-on
Omni Life Science, Inc.
NS-27008
In Commercial Distribution

  • 00841690194521 ()
NS-27008

  • Instrument tray, reusable
Knee Software Package, ART 2.2 Add-on
Omni Life Science, Inc.
NS-27009
In Commercial Distribution

  • 00841690194514 ()
NS-27009

  • Instrument tray, reusable
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