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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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AUDIGY - 00842318177759

No Description
STARKEY LABORATORIES, INC.
AUDIGY AGXSLIV EDGE AI 2400 BTE R
In Commercial Distribution

  • 00842318177759 ()
63196-A

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

AUDIGY - 00842318177742

No Description
STARKEY LABORATORIES, INC.
AUDIGY AGXSLIV EDGE AI 2400 BTE 13
In Commercial Distribution

  • 00842318177742 ()
63195-A

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

AUDIBEL - 00842318177506

No Description
STARKEY LABORATORIES, INC.
AUDIBEL VIA EDGE AI CROSBICROS RIC R
In Commercial Distribution

  • 00842318177506 ()
63199-2

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

AUDIBEL - 00842318177490

No Description
STARKEY LABORATORIES, INC.
AUDIBEL VIA EDGE AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318177490 ()
63200-2

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

AUDIBEL - 00842318177483

No Description
STARKEY LABORATORIES, INC.
AUDIBEL VIA EDGE AI CROSBICROS BTE 13
In Commercial Distribution

  • 00842318177483 ()
63198-2

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

AUDIBEL - 00842318177476

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

  • 00842318177476 ()
63194-2, 63206-2

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

AUDIBEL - 00842318177469

No Description
STARKEY LABORATORIES, INC.
AUDIBEL VIA EDGE AI 2400 RIC 312
In Commercial Distribution

  • 00842318177469 ()
63192-2, 63205-2

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

AUDIBEL - 00842318177452

No Description
STARKEY LABORATORIES, INC.
AUDIBEL VIA EDGE AI 2400 MRIC 312
In Commercial Distribution

  • 00842318177452 ()
63193-2, 63204-2

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

AUDIBEL - 00842318177445

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

  • 00842318177445 ()
63208-ABL

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

AUDIBEL - 00842318177438

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

  • 00842318177438 ()
63196-2, 63207-2

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