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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 - 09321502052993

No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution

  • 09321502052993 ()
P1646054

  • Audiometric/hearing device software

Nucleus - 09321502036788

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

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software

Cochlear™ Baha® Fitting Software - 09321502036030

Program Baha Sound Processors
Cochlear Bone Anchored Solutions AB
P803255
In Commercial Distribution

  • 09321502036030 ()
P803255

  • 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

Sonic - 05711583038209

EXPRESSFIT PRO 2020.1
Sonic Innovations, Inc.
214708
In Commercial Distribution

  • 05711583038209 ()


  • Audiometric/hearing device software

Sonic - 05711583037479

EXPRESSFIT PRO 2019.2
Sonic Innovations, Inc.
204549
In Commercial Distribution

  • 05711583037479 ()


  • Audiometric/hearing device software

Sonic - 05711583033488

EXPRESSFIT PRO 2019.1
Sonic Innovations, Inc.
196004
In Commercial Distribution

  • 05711583033488 ()


  • Audiometric/hearing device software

Sonic - 05711583031903

EXPRESSFIT PRO 2018.2
Sonic Innovations, Inc.
190061
In Commercial Distribution

  • 05711583031903 ()


  • Audiometric/hearing device software

Bernafon - 05711584075999

OASIS NXT 2017.1 CUSTOM
Bernafon AG
181794
In Commercial Distribution

  • 05711584075999 ()


  • Audiometric/hearing device software
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