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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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CUSTOM SOUND SUITE 3.1 ENGLISH (US) - 09321502019873

CUSTOM SOUND SUITE 3.1 ENGLISH (US)
COCHLEAR LIMITED
Z248940
In Commercial Distribution

  • 09321502019873 ()
Z248940

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 2.0 SR2 US ENGLISH - 09321502018913

CUSTOM SOUND SUITE 2.0 SR2 US ENGLISH
COCHLEAR LIMITED
Z229456
In Commercial Distribution

  • 09321502018913 ()
Z229456

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 3.0 US ENGLISH - 09321502018906

CUSTOM SOUND SUITE 3.0 US ENGLISH
COCHLEAR LIMITED
Z220129
In Commercial Distribution

  • 09321502018906 ()
Z220129

  • Audiometric/hearing device software

CLINICAL PROGRAMMING SYSTEM - 09321502002448

CLINICAL PROGRAMMING SYSTEM
COCHLEAR LIMITED
Z43102
In Commercial Distribution

  • 09321502002448 ()
Z43102

  • 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

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

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
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