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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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AESCULAP - 04046963895860

ORTHOPILOT SOFTWARE ACL SGL.+DBL.BUNDLE
Aesculap AG
FS227
Not in Commercial Distribution

  • 04046963895860 ()
FS227

  • Robotic surgical navigation system application software

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 - 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

EchoPAC - 00195278504302

MD EchoPAC Software Only v206
GE Vingmed Ultrasound AS
Software Only v206
In Commercial Distribution

  • 00195278504302 ()


  • Ultrasound imaging system application software

Kinesia 360 - 00859584006171

Kinesia 360 Support Application Software
Great Lakes Neurotechnologies Inc.
360-0048, Support Application Software
In Commercial Distribution

  • 00859584006171 ()


  • Tremor transducer

Cycler Control v2.2 - 00858637005871

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

  • 00858637005871 ()


  • Laboratory instrument/analyser application software IVD

STARlet Interface v2.2 - 00858637005864

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

  • 00858637005864 ()


  • Laboratory instrument/analyser application software IVD

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

Nexstim NBS software GER - 06430063200064

Nexstim NBS German Main Software
NEXSTIM, INC.
5
In Commercial Distribution

  • 06430063200064 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
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