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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 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

CUSTOM SOUND PRO 7.0 CD - 09321502074148

No Description
Cochlear Americas Corporation
P2002452CD
In Commercial Distribution

  • 09321502074148 ()


  • Audiometric/hearing device software

OSIA FITTING SOFTWARE 2 CD - 09321502074131

No Description
Cochlear Americas Corporation
P1348428CD
In Commercial Distribution

  • 09321502074131 ()


  • Audiometric/hearing device software

Custom Sound® Pro - 09321502065948

No Description
COCHLEAR LIMITED
7.0
In Commercial Distribution

  • 09321502065948 ()
P1846133

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502065764

for iOS
COCHLEAR LIMITED
6.0
In Commercial Distribution

  • 09321502065764 ()
P1861019

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502065757

for Android
COCHLEAR LIMITED
6.0
In Commercial Distribution

  • 09321502065757 ()
P1860864

  • 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

Cochlear™ Custom Sound® Suite Version 5.2 - 09321502044943

downloadable
COCHLEAR LIMITED
P1487112
In Commercial Distribution

  • 09321502044943 ()
P1487112

  • Audiometric/hearing device software
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