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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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not applicable - 00195278795724

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

MPXA - 08800127400040

AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE
Medipixel
V1.0.0
In Commercial Distribution

  • 08800127400040 ()


  • Radiology DICOM image processing application software

KARL STORZ SCB - 04048551060599

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

n.a. - 04048551329856

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-44
In Commercial Distribution

  • 04048551329856 ()


  • Operating room audiovisual data/device management system application software

n.a. - 04048551357286

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-45
In Commercial Distribution

  • 04048551357286 ()


  • Operating room audiovisual data/device management system application software

NA - 00840682107990

MR Applications Software MP24 R01
GENERAL ELECTRIC COMPANY
MP24
Not in Commercial Distribution

  • 00840682107990 ()


  • Full-body MRI system, superconducting magnet
  • PET system

INW Server - 00840682145756

Software Medical Device INW V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145756 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

INW Server - 00840682123563

SOFTWARE INW SERVER V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123563 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

AVEA - 10846446000979

KIT,AVEA UPGRADE UIM & SOFTWARE
Carefusion Corporation
12285
Not in Commercial Distribution

  • 10846446000979 ()


  • Ventilator application software

Vela - 10846446012705

KIT,ET-CO2 MODULE W/SOFTWARE
Carefusion Corporation
16920
Not in Commercial Distribution

  • 10846446012705 ()
16920

  • Carbon dioxide sensor/cable
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