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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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LATITUDE Consult™ - 00802526562914

LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562914 ()


  • Cardiac pulse generator software

LATITUDE Consult™ - 00802526562907

LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562907 ()


  • Cardiac pulse generator software

Merlin™ - 05415067037121

2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software

CareLink® - 00643169288409

SOFTWARE MMT-7335 V3.4 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
In Commercial Distribution

  • 00643169288409 ()


  • Patient health record information system application software

not applicable - 00195278719812

Software Pristina ME 9.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA ME 9.2
In Commercial Distribution

  • 00195278719812 ()


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

CareLink® - 00613994342805

SOFTWARE MMT-7335 CD-ROM CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00613994342805 ()


  • Patient health record information system application software

CareLink® - 00643169175341

SOFTWARE MMT-7335 V3.2 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00643169175341 ()


  • Patient health record information system application software

Nucleus® Smart App - 09321502065764

Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502065757

Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM - 09321502029469

CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM
COCHLEAR LIMITED
Z494179
In Commercial Distribution

  • 09321502029469 ()
Z494179

  • Audiometric/hearing device software
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