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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 - 00840388204276

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 20 RIC 312
In Commercial Distribution

  • 00840388204276 ()


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

AUDIOSYNC - 00840388204115

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 24 RIC 312 (DEMO)
In Commercial Distribution

  • 00840388204115 ()


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

NUEAR - 00840388204085

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 24 RIC 312 (DEMO)
In Commercial Distribution

  • 00840388204085 ()


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

AUDIBEL - 00840388204078

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 24 RIC 312 (DEMO)
In Commercial Distribution

  • 00840388204078 ()


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

STARKEY - 00840388204061

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 RIC 312 (DEMO)
In Commercial Distribution

  • 00840388204061 ()


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

AUDIGY - 00840388204016

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI CROS RIC 312
In Commercial Distribution

  • 00840388204016 ()


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

AUDIGY - 00840388203927

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 24 RIC 312
In Commercial Distribution

  • 00840388203927 ()


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

AUDIGY - 00840388203811

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 16 MRIC R
In Commercial Distribution

  • 00840388203811 ()


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

AUDIGY - 00840388203736

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 20 MRIC R
In Commercial Distribution

  • 00840388203736 ()


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

AUDIOSYNC - 00840388203545

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 24 MRIC R (DEMO)
In Commercial Distribution

  • 00840388203545 ()


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

NUEAR - 00840388203507

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 24 MRIC R (DEMO)
In Commercial Distribution

  • 00840388203507 ()


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

AUDIBEL - 00840388203491

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 24 MRIC R (DEMO)
In Commercial Distribution

  • 00840388203491 ()


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

STARKEY - 00840388203484

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 MRIC R (DEMO)
In Commercial Distribution

  • 00840388203484 ()


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

AUDIGY - 00840388203415

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 24 MRIC R
In Commercial Distribution

  • 00840388203415 ()


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

AUDIGY - 00840388203293

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 16 RIC RT
In Commercial Distribution

  • 00840388203293 ()


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

AUDIGY - 00840388203217

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 20 RIC RT
In Commercial Distribution

  • 00840388203217 ()


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

AUDIGY - 00840388203125

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI CROS RIC RT
In Commercial Distribution

  • 00840388203125 ()


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

AUDIGY - 00840388203040

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 24 RIC RT
In Commercial Distribution

  • 00840388203040 ()


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

STARKEY - 00840388202708

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 24 RIC RT (SCIF)
In Commercial Distribution

  • 00840388202708 ()


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

STARKEY - 00840388201145

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 24 CIC NW (GS)
In Commercial Distribution

  • 00840388201145 ()


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

AUDIGY - 00840388200483

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI CROSBICROS RIC 312
In Commercial Distribution

  • 00840388200483 ()


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

MICROTECH - 00840388200476

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI CROSBICROS RIC 312
In Commercial Distribution

  • 00840388200476 ()


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

AUDIGY - 00840388200377

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI 12 RIC 312
In Commercial Distribution

  • 00840388200377 ()


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

MICROTECH - 00840388200360

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI 12 RIC 312
In Commercial Distribution

  • 00840388200360 ()


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

NUEAR - 00840388200353

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI 12 RIC 312
In Commercial Distribution

  • 00840388200353 ()


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

AUDIGY - 00840388200261

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI 16 RIC 312
In Commercial Distribution

  • 00840388200261 ()


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

MICROTECH - 00840388200254

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI 16 RIC 312
In Commercial Distribution

  • 00840388200254 ()


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

NUEAR - 00840388200247

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI 16 RIC 312
In Commercial Distribution

  • 00840388200247 ()


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

AUDIGY - 00840388200155

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI 20 RIC 312
In Commercial Distribution

  • 00840388200155 ()


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

MICROTECH - 00840388200148

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI 20 RIC 312
In Commercial Distribution

  • 00840388200148 ()


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

NUEAR - 00840388200131

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI 20 RIC 312
In Commercial Distribution

  • 00840388200131 ()


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

STARKEY - 00840388200094

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 24 RIC 312 (GS)
In Commercial Distribution

  • 00840388200094 ()


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

AUDIGY - 00840388200032

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI 24 RIC 312
In Commercial Distribution

  • 00840388200032 ()


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

MICROTECH - 00840388200025

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI 24 RIC 312
In Commercial Distribution

  • 00840388200025 ()


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

NUEAR - 00840388200018

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI 24 RIC 312
In Commercial Distribution

  • 00840388200018 ()


  • Air-conduction hearing aid, receiver-in-canal
  • 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
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