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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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STARKEY LABORATORIES, INC.
NUEAR CIRCA EDGE AI 2400 ITC R
In Commercial Distribution

  • 00842318180858 ()
63230-NUE

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
MICROTECH ESENTIA EDGE AI 2400 ITC R
In Commercial Distribution

  • 00842318180841 ()
63230-MIC

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
STARKEY LABORATORIES, INC.
AUDIGY AGXSLIV EDGE AI 2400 ITC R
In Commercial Distribution

  • 00842318180810 ()
63230-AUY

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
AUDIOSYNC VIA EDGE AI 2400 ITC R
In Commercial Distribution

  • 00842318180803 ()
63230-ASY

  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
STARKEY LABORATORIES, INC.
AUDIBEL VIA EDGE AI 2400 ITC R
In Commercial Distribution

  • 00842318180797 ()
63230-ABL

  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
STARKEY LIVIO EDGE AI 2400 ITE R
In Commercial Distribution

  • 00842318180094 ()
63219-SHT

  • Tinnitus masking application software
  • Air-conduction hearing aid, in-the-ear
No Description
STARKEY LABORATORIES, INC.
NUEAR CIRCA EDGE AI 2400 ITE R
In Commercial Distribution

  • 00842318180087 ()
63219-NUE

  • Tinnitus masking application software
  • Air-conduction hearing aid, in-the-ear
No Description
STARKEY LABORATORIES, INC.
MICROTECH ESENTIA EDGE AI 2400 ITE R
In Commercial Distribution

  • 00842318180070 ()
63219-MIC

  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
AUDIGY AGXSLIV EDGE AI 2400 ITE R
In Commercial Distribution

  • 00842318180056 ()
63219-AUY

  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
AUDIOSYNC VIA EDGE AI 2400 ITE R
In Commercial Distribution

  • 00842318180049 ()
63219-ASY

  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software
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