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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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Compumedics Grael - 09342451001290

Grael LT System, no software
COMPUMEDICS LIMITED
Grael LT
In Commercial Distribution

  • 09342451001290 ()
9028-0008-01

  • Electroencephalograph

Compumedics Grael - 09342451001276

Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph

Sleepware - 00606959045279

Software, Sleepware G3, Web download
Respironics, Inc.
Sleepware G3 Software, Web download - 3
In Commercial Distribution

  • 00606959045279 ()
1115720

  • Polysomnography analyser

Actiware - 00606959040366

Actiware Clinical Trial Software, English
Respironics, Inc.
Actiware Clinical Trial Software, English - 6
In Commercial Distribution

  • 00606959040366 ()
1103609

  • Kinesiology ambulatory recorder

Sleepware - 00606959038943

Sleepware G3 Software Package, Japan
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959038943 ()
1121998

  • Polysomnography analyser

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 - 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 - 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 - 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
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