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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 4.1 SP3 (US) - CD - 09321502029452

CUSTOM SOUND SUITE 4.1 SP3 (US) - CD
COCHLEAR LIMITED
Z540369
In Commercial Distribution

  • 09321502029452 ()
Z540369

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 ROW-CANADA - 09321502029445

CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 ROW-CANADA
COCHLEAR LIMITED
Z532157
In Commercial Distribution

  • 09321502029445 ()
Z532157

  • 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

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

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 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

CUSTOM SOUND SUITE 2.0 SR1 FRENCH - 09321502011921

CUSTOM SOUND SUITE 2.0 SR1 FRENCH
COCHLEAR LIMITED
Z194952
In Commercial Distribution

  • 09321502011921 ()
Z194952

  • Audiometric/hearing device software

CUSTOM SND SUITE 1.3 SERV RELEASE 1 - 09321502011624

CUSTOM SND SUITE 1.3 SERV RELEASE 1
COCHLEAR LIMITED
Z61155
In Commercial Distribution

  • 09321502011624 ()
Z61155

  • Audiometric/hearing device software
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