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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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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™ Custom Sound® Suite - 09321502044936

Version 5.2
COCHLEAR LIMITED
P1487131
In Commercial Distribution

  • 09321502044936 ()
P1487131

  • Audiometric/hearing device software

Nucleus - 09321502043236

Nucleus Smart App
COCHLEAR LIMITED
P1285539
In Commercial Distribution

  • 09321502043236 ()
P1285539

  • Audiometric/hearing device software

Nucleus - 09321502043212

Custom Sound Suite 5.1 Download
COCHLEAR LIMITED
P1256009
In Commercial Distribution

  • 09321502043212 ()
P1256009

  • Audiometric/hearing device software

Nucleus - 09321502043205

Custom Sound Suite 5.1 CD
COCHLEAR LIMITED
P1257243
In Commercial Distribution

  • 09321502043205 ()
P1257243

  • Audiometric/hearing device software

Cochlear™ Custom Sound Suite Version 5 - 09321502038829

CD
COCHLEAR LIMITED
P772796
In Commercial Distribution

  • 09321502038829 ()
P772796

  • Audiometric/hearing device software

Cochlear™ Custom Sound Suite Version 5 - 09321502038812

Download
COCHLEAR LIMITED
P772803
In Commercial Distribution

  • 09321502038812 ()
P772803

  • Audiometric/hearing device software

Cochlear - 09321502046145

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

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software

Cochlear - 09321502046138

Osia Smart App (iOS)
COCHLEAR LIMITED
P1340352
In Commercial Distribution

  • 09321502046138 ()
P1340352

  • Audiometric/hearing device software
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