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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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Nucleus® SmartNav - 09321502065917

Hearing implant software
COCHLEAR LIMITED
P1799437
In Commercial Distribution

  • 09321502065917 ()
P1799437

  • Cochlear implant intraoperative electrophysiological analysis software

Custom Sound Pro - 09321502072359

Hearing implant software
COCHLEAR LIMITED
v7.1, US
In Commercial Distribution

  • 09321502072359 ()
P1947519

  • Audiometric/hearing device software

Cochlear™ Objective Measures - 09321502070416

Hearing implant software
COCHLEAR LIMITED
v 2.0
In Commercial Distribution

  • 09321502070416 ()
P1986795

  • Cochlear implant intraoperative electrophysiological analysis software

not applicable - 00840682146845

Software Pristina Infinity
GE MEDICAL SYSTEMS
PRISTINA 2.0
In Commercial Distribution

  • 00840682146845 ()


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

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

WAVENET - 00380650004567

WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software

RMS - 08031527021188

Remote Monitoring Software
MICROPORT CRM SRL
RMS
In Commercial Distribution

  • 08031527021188 ()
RMS

  • Cardiology information system application software

N'VISION® - 00643169955653

SOFTWARE 8870AAV01 N'VISION US
MEDTRONIC, INC.
8870AAV01
In Commercial Distribution

  • 00643169955653 ()


  • Multiple active implantable device programmer

TriageHF™ - 00763000351656

SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software
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