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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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Natus - 00382830037969

EMG v21.1.0 Application Software CD
NATUS NEUROLOGY INCORPORATED
482-651200
In Commercial Distribution

  • 00382830037969 ()


  • Electromyograph

Natus - 00382830036160

EMG Software Upgrade to v22.4
NATUS NEUROLOGY INCORPORATED
688-628500
In Commercial Distribution

  • 00382830036160 ()


  • Electromyograph

Natus - 00382830036153

EMG Software Update to v22.3
NATUS NEUROLOGY INCORPORATED
688-628600
In Commercial Distribution

  • 00382830036153 ()


  • Electromyograph

Natus - 00382830035033

Natus Elite - Synergy Master Software
NATUS NEUROLOGY INCORPORATED
828-069300
In Commercial Distribution

  • 00382830035033 ()


  • Electromyograph

Natus - 00382830035026

Natus Elite - Viking Master Software
NATUS NEUROLOGY INCORPORATED
828-069400
In Commercial Distribution

  • 00382830035026 ()


  • Electromyograph

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

EchoPAC - 00195278504302

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

  • 00195278504302 ()


  • Ultrasound imaging system application software

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
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