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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 Class Implantable

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SAMBA 2 Remote (iOS) - 09008737526030

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52603
In Commercial Distribution

  • 09008737526030 ()


  • Audiometric/hearing device software

SAMBA 2 Remote (Android) - 09008737520472

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52047
In Commercial Distribution

  • 09008737520472 ()


  • Audiometric/hearing device software

AudioKey 2.0 - 09008737379353

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37935
In Commercial Distribution

  • 09008737379353 ()


  • Audiometric/hearing device software

AudioKey 1.0 - 09008737097493

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09749
Not in Commercial Distribution

  • 09008737097493 ()


  • Audiometric/hearing device software

HearCare MED-EL - 09008737433079

Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
43307
In Commercial Distribution

  • 09008737433079 ()


  • Audiometric/hearing device software

HearCare MED-EL - 09008737431716

Mobile application (Android)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
43171
In Commercial Distribution

  • 09008737431716 ()


  • Audiometric/hearing device software

AudioKey 3 - 09008737413422

Mobile application (Android)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41342
In Commercial Distribution

  • 09008737413422 ()


  • Audiometric/hearing device software

AudioKey 3 - 09008737413415

Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41341
In Commercial Distribution

  • 09008737413415 ()


  • Audiometric/hearing device software

SoundWave™ Professional Suite Software - 00840094448155

3.2
Advanced Bionics, LLC
CI-6055-014
In Commercial Distribution



  • Audiometric/hearing device software

SoundWave™ Professional Suite Software - 00840094448148

3.1
Advanced Bionics, LLC
CI-6055-011
In Commercial Distribution



  • Audiometric/hearing device software
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