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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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OMNIBotics - 00841690194545

Knee Software Package
Omni Life Science, Inc.
NS-27003
In Commercial Distribution

  • 00841690194545 ()
NS-27003

  • Instrument tray, reusable

EncorePro 2, Software - 00606959050778

EncorePro 2, Software
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959050778 ()
1054785

  • Medical equipment clinical data interfacing software

EncorePro 2, Software - 00606959048348

EncorePro 2, Software
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048348 ()
1054785

  • Medical equipment clinical data interfacing software

EncorePro - 00606959048331

Software, EncorePro2, web
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048331 ()
1099731

  • Medical equipment clinical data interfacing software

OmniLab Direct - 00606959044302

OmniLab Direct Software
Respironics, Inc.
OmniLab Direct Software - 2
In Commercial Distribution

  • 00606959044302 ()
1112033

  • Clinical laboratory information system

EncorePro - 00606959040434

Software, EncorePro2, web
Respironics, Inc.
2.19
In Commercial Distribution

  • 00606959040434 ()
1099731

  • Medical equipment clinical data interfacing software

not applicable - 00195278711229

UDI Software Pristina
GE MEDICAL SYSTEMS
PRISTINA 2.8.3
In Commercial Distribution

  • 00195278711229 ()


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

not applicable - 00195278009289

M3.3 UP4 software
GE MEDICAL SYSTEMS
PRISTINA 0.0B
In Commercial Distribution

  • 00195278009289 ()


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

PULSE - 00195377065544

PULSE Software, v4.0.0-bln.eu
Nuvasive, Inc.
1802497
In Commercial Distribution

  • 00195377065544 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065537

PULSE Software, v4.0.0-bln.us
Nuvasive, Inc.
1802495
In Commercial Distribution

  • 00195377065537 ()


  • Orthopaedic stereotactic surgery system
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