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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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Analysis Client v2.2 - 00858637005857

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005857 ()


  • Laboratory instrument/analyser application software IVD

Analysis Server v2.2 - 00858637005840

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005840 ()


  • Laboratory instrument/analyser application software IVD

Vivistim - 10810041430004

Stroke Application and Programming Software
Microtransponder
4001
In Commercial Distribution

  • 10810041430004 ()


  • Vagus nerve electrical stimulation system programmer

Neuro Cochlear Implant System - 03663227001532

Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit

not applicable - 00195278866899

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

not applicable - 00195278716026

UDI Software Pristina ME 9.1
GE MEDICAL SYSTEMS
PRISTINA ME 9.1
In Commercial Distribution

  • 00195278716026 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

not applicable - 00195278655141

Software Pristina 8.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.2
In Commercial Distribution

  • 00195278655141 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

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

not applicable - 00195278560049

Software Pristina 8.1 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8
In Commercial Distribution

  • 00195278560049 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit

MAXPOINT BR-I - 07290107983136

Transducer Array Layout Planning software
Novocure GmbH
1.1.0
In Commercial Distribution

  • 07290107983136 ()
SW000060

  • Alternating electric field antimitotic cancer treatment system generator
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