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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 3.1 SPANISH (US) - 09321502029520

CUSTOM SOUND SUITE 3.1 SPANISH (US)
COCHLEAR LIMITED
Z248945
In Commercial Distribution

  • 09321502029520 ()
Z248945

  • 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 3.2 ENGLISH (US) - 09321502020480

CUSTOM SOUND SUITE 3.2 ENGLISH (US)
COCHLEAR LIMITED
Z274923
In Commercial Distribution

  • 09321502020480 ()
Z274923

  • 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

Cochlear™ Baha® Fitting Software 6 - 09321502053037

No Description
Cochlear Bone Anchored Solutions AB
P1701584
In Commercial Distribution

  • 09321502053037 ()
P1701584

  • Audiometric/hearing device software

Cochlear™ Baha® Fitting Software 6 - 09321502053013

No Description
Cochlear Bone Anchored Solutions AB
P1682914
In Commercial Distribution

  • 09321502053013 ()
P1682914

  • Audiometric/hearing device software

Baha Smart App - 09321502053006

No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution

  • 09321502053006 ()
P1646035

  • Audiometric/hearing device software

Baha Smart App - 09321502052993

No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution

  • 09321502052993 ()
P1646054

  • Audiometric/hearing device software

Cochlear - 09321502046145

Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software

Cochlear™ Custom Sound Suite Version 5 - 09321502038829

CD
COCHLEAR LIMITED
P772796
In Commercial Distribution

  • 09321502038829 ()
P772796

  • Audiometric/hearing device software
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