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 Size Device Size Type Device Class Implantable

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No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 1000 RIC 312
In Commercial Distribution

  • 00842318184054 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 1200 RIC 312
In Commercial Distribution

  • 00842318184047 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 1600 RIC 312
In Commercial Distribution

  • 00842318184030 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 2000 RIC 312
In Commercial Distribution

  • 00842318184023 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 2400 RIC 312
In Commercial Distribution

  • 00842318184016 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 1000 RIC 312
In Commercial Distribution

  • 00842318183996 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 1200 RIC 312
In Commercial Distribution

  • 00842318183989 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 1600 RIC 312
In Commercial Distribution

  • 00842318183972 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 2000 RIC 312
In Commercial Distribution

  • 00842318183965 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 2400 RIC 312
In Commercial Distribution

  • 00842318183958 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 1000 RIC 312
In Commercial Distribution

  • 00842318183934 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 1200 RIC 312
In Commercial Distribution

  • 00842318183927 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 1600 RIC 312
In Commercial Distribution

  • 00842318183910 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 2000 RIC 312
In Commercial Distribution

  • 00842318183903 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 2400 RIC 312
In Commercial Distribution

  • 00842318183897 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI 1000 ITC R
In Commercial Distribution

  • 00842318181237 ()
63235-SHT

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
NUEAR CIRCA AI 1000 ITC R
In Commercial Distribution

  • 00842318181220 ()
63235-NUE

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI 1000 ITC R
In Commercial Distribution

  • 00842318181213 ()
63235-MIC

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1000 ITC R
In Commercial Distribution

  • 00842318181183 ()
63235-AUY

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI 1000 ITC R
In Commercial Distribution

  • 00842318181176 ()
63235-ASY

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1000 ITC R
In Commercial Distribution

  • 00842318181169 ()
63235-ABL

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI 1200 ITC R
In Commercial Distribution

  • 00842318181152 ()
63234-SHT

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
NUEAR CIRCA AI 1200 ITC R
In Commercial Distribution

  • 00842318181145 ()
63234-NUE

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI 1200 ITC R
In Commercial Distribution

  • 00842318181138 ()
63234-MIC

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1200 ITC R
In Commercial Distribution

  • 00842318181107 ()
63234-AUY

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI 1200 ITC R
In Commercial Distribution

  • 00842318181091 ()
63234-ASY

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1200 ITC R
In Commercial Distribution

  • 00842318181084 ()
63234-ABL

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI 1600 ITC R
In Commercial Distribution

  • 00842318181077 ()
63233-SHT

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
NUEAR CIRCA AI 1600 ITC R
In Commercial Distribution

  • 00842318181060 ()
63233-NUE

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI 1600 ITC R
In Commercial Distribution

  • 00842318181053 ()
63233-MIC

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
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