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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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Beltone - 05708296077038

SW,FSW,BT,SOLUS PRO 1.11
Gn Hearing A/S
20450300
In Commercial Distribution

  • 05708296077038 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077021

SW,FSW,RS AVENTA 3.11
Gn Hearing A/S
20450200
In Commercial Distribution

  • 05708296077021 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077014

SW,FSW,AUDIGY 1.0
Gn Hearing A/S
20449000
In Commercial Distribution

  • 05708296077014 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077007

USB,FSW,AUDIGY 1.0
Gn Hearing A/S
20448900
In Commercial Distribution

  • 05708296077007 ()


  • Audiometric/hearing device software

Beltone - 05708296076789

DVD,FSW,BT SOLUS MAX 1.0
Gn Hearing A/S
20439610
In Commercial Distribution

  • 05708296076789 ()


  • Audiometric/hearing device software

GN ReSound - 05708296076772

DVD,FSW,RS SMART FIT 1.0
Gn Hearing A/S
20439510
In Commercial Distribution

  • 05708296076772 ()


  • Audiometric/hearing device software

Beltone - 05708296076765

DVD,AIRLINK 2 UPDATE,BT
Gn Hearing A/S
20538700
In Commercial Distribution

  • 05708296076765 ()


  • Audiometric/hearing device software

Lexie Hearing - 00850022464263

iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software

Lexie Hearing - 00850022464256

Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software

SoundWave™ Professional Suite Software - 07630016816925

2.2.25
Advanced Bionics, LLC
CI-6055-008
Not in Commercial Distribution

  • 07630016816925 ()


  • Audiometric/hearing device software
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