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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 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 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

CLINICAL PROGRAMMING SYSTEM - 09321502002448

CLINICAL PROGRAMMING SYSTEM
COCHLEAR LIMITED
Z43102
In Commercial Distribution

  • 09321502002448 ()
Z43102

  • Audiometric/hearing device software

Nucleus - 09321502036788

Nucleus Smart App, (iOS)
COCHLEAR LIMITED
P832154
In Commercial Distribution

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software

Custom Sound Suite 4.4 CD - 09321502033381

Version 4.4 CD
COCHLEAR LIMITED
P705394
In Commercial Distribution

  • 09321502033381 ()
P705394

  • Audiometric/hearing device software

Custom Sound Suite 4.4 Download - 09321502033374

Custom Sound Suite 4.4 Download
COCHLEAR LIMITED
P705392
In Commercial Distribution

  • 09321502033374 ()
P705392

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 CAM - 09321502029612

CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 CAM
COCHLEAR LIMITED
Z532160
In Commercial Distribution

  • 09321502029612 ()
Z532160

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH - 09321502029599

CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH
COCHLEAR LIMITED
Z361240
In Commercial Distribution

  • 09321502029599 ()
Z361240

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 3.2 FRENCH (US) - 09321502029551

CUSTOM SOUND SUITE 3.2 FRENCH (US)
COCHLEAR LIMITED
Z301344
In Commercial Distribution

  • 09321502029551 ()
Z301344

  • Audiometric/hearing device software
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