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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COMPASS GPS V2.0 package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069588125 ()
7 503 0110 004

  • Audiometric/hearing device software
COMPASS GPS V2.0 package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069588118 ()
7 503 0110 003

  • Audiometric/hearing device software
COMPASS GPS V2.0 package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069588101 ()
7 503 0110 002

  • Audiometric/hearing device software
COMPASS GPS V2.0 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069588095 ()
7 503 0110 001

  • Audiometric/hearing device software
APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990020-SWH
In Commercial Distribution

  • 00850016231390 ()


  • Audiometric/hearing device software
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
AudigyFit 2 2023.1
Sbo Hearing A/S
255010
In Commercial Distribution

  • 05714464097036 ()


  • Audiometric/hearing device software
Oticon Genie 2 2023.1
Sbo Hearing A/S
255009
In Commercial Distribution

  • 05714464097029 ()


  • Audiometric/hearing device software
Oticon Genie 2 2023.1 VA
Sbo Hearing A/S
255007
In Commercial Distribution

  • 05714464097005 ()


  • Audiometric/hearing device software
Philips HearSuite 2023.1 TRO
Sbo Hearing A/S
253223
In Commercial Distribution

  • 05714464095667 ()


  • Audiometric/hearing device software
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