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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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CUSTOM SOUND SUITE 3.0 SPANISH (US) - 09321502029513

CUSTOM SOUND SUITE 3.0 SPANISH (US)
COCHLEAR LIMITED
Z239932
In Commercial Distribution

  • 09321502029513 ()
Z239932

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 3.0 FRENCH (US) - 09321502029506

CUSTOM SOUND SUITE 3.0 FRENCH (US)
COCHLEAR LIMITED
Z239930
In Commercial Distribution

  • 09321502029506 ()
Z239930

  • Audiometric/hearing device software

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 3.0 US ENGLISH - 09321502018906

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

  • 09321502018906 ()
Z220129

  • Audiometric/hearing device software

Baha Smart App - 09321502078962

iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software

Baha Smart App - 09321502078955

Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078955 ()
P1646035

  • Audiometric/hearing device software

Lexie Hearing - 00850022464263

iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software

Lexie Hearing - 00850022464256

Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • 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
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