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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 DAL SR US ENGLISH - 09321502029537

CUSTOM SOUND SUITE 3.0 DAL SR US ENGLISH
COCHLEAR LIMITED
Z252571
In Commercial Distribution

  • 09321502029537 ()
Z252571

  • Audiometric/hearing device software

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 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 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

Nucleus® Smart App - 09321502060486

for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502060479

for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software

Custom Sound® Pro - 09321502057332

No Description
COCHLEAR LIMITED
6.2
In Commercial Distribution

  • 09321502057332 ()
P1774431

  • Audiometric/hearing device software
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