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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 Size Device Size Type Device Class Implantable

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MICROTECH - 00842318180971

No Description
STARKEY LABORATORIES, INC.
MICROTECH ESENTIA AI 2000 ITC R
In Commercial Distribution

  • 00842318180971 ()
63232-MIC

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

AUDIGY - 00842318180957

No Description
STARKEY LABORATORIES, INC.
AUDIGY AGXSLIV AI 2000 ITC R
In Commercial Distribution

  • 00842318180957 ()
63232-AUY

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

AUDIBEL - 00842318180933

No Description
STARKEY LABORATORIES, INC.
AUDIBEL VIA AI 2000 ITC R
In Commercial Distribution

  • 00842318180933 ()
63232-ABL

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

MICROTECH - 00842318180902

No Description
STARKEY LABORATORIES, INC.
MICROTECH ESENTIA AI 2400 ITC R
In Commercial Distribution

  • 00842318180902 ()
63231-MIC

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

AUDIBEL - 00842318180872

No Description
STARKEY LABORATORIES, INC.
AUDIBEL VIA AI 2400 ITC R
In Commercial Distribution

  • 00842318180872 ()
63231-ABL

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

AUDIGY - 00842318181183

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

AUDIOSYNC - 00842318181176

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

STARKEY - 00842318181152

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

MICROTECH - 00842318181138

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

AUDIOSYNC - 00842318181091

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
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