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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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AUDIBEL - 00840388201169

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI RIC RT
In Commercial Distribution

  • 00840388201169 ()


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

STARKEY - 00840388201152

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI RIC RT
In Commercial Distribution

  • 00840388201152 ()


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

STARKEY - 00840388204849

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 12 CIC
In Commercial Distribution

  • 00840388204849 ()


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

NUEAR - 00840388204832

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 12 CIC
In Commercial Distribution

  • 00840388204832 ()


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

AUDIOSYNC - 00840388204788

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 12 CIC
In Commercial Distribution

  • 00840388204788 ()


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

AUDIBEL - 00840388204764

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 12 CIC
In Commercial Distribution

  • 00840388204764 ()


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

STARKEY - 00840388204740

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 16 CIC
In Commercial Distribution

  • 00840388204740 ()


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

NUEAR - 00840388204726

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 16 CIC
In Commercial Distribution

  • 00840388204726 ()


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

AUDIOSYNC - 00840388204672

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 16 CIC
In Commercial Distribution

  • 00840388204672 ()


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

AUDIBEL - 00840388204658

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 16 CIC
In Commercial Distribution

  • 00840388204658 ()


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

STARKEY - 00840388204641

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 20 CIC
In Commercial Distribution

  • 00840388204641 ()


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

NUEAR - 00840388204634

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 20 CIC
In Commercial Distribution

  • 00840388204634 ()


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

AUDIOSYNC - 00840388204580

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 20 CIC
In Commercial Distribution

  • 00840388204580 ()


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

AUDIBEL - 00840388204566

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 20 CIC
In Commercial Distribution

  • 00840388204566 ()


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

NUEAR - 00840388204559

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 24 CIC
In Commercial Distribution

  • 00840388204559 ()


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

STARKEY - 00840388204528

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 CIC
In Commercial Distribution

  • 00840388204528 ()


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

AUDIOSYNC - 00840388204498

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 24 CIC
In Commercial Distribution

  • 00840388204498 ()


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

AUDIBEL - 00840388204474

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 24 CIC
In Commercial Distribution

  • 00840388204474 ()


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

AUDIOSYNC - 00840388204412

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI RIC 312
In Commercial Distribution

  • 00840388204412 ()


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

AUDIBEL - 00840388204399

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI RIC 312
In Commercial Distribution

  • 00840388204399 ()


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

STARKEY - 00840388204382

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI RIC 312
In Commercial Distribution

  • 00840388204382 ()


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

AUDIOSYNC - 00840388203873

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI MRIC R
In Commercial Distribution

  • 00840388203873 ()


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

AUDIBEL - 00840388203866

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI MRIC R
In Commercial Distribution

  • 00840388203866 ()


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

AUDIOSYNC - 00840388203361

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI RIC RT
In Commercial Distribution

  • 00840388203361 ()


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

AUDIBEL - 00840388203347

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI RIC RT
In Commercial Distribution

  • 00840388203347 ()


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

STARKEY - 00840388203330

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI RIC RT
In Commercial Distribution

  • 00840388203330 ()


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

STARKEY - 00840388202906

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 CIC
In Commercial Distribution

  • 00840388202906 ()


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

STARKEY - 00840388202869

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI MRIC R
In Commercial Distribution

  • 00840388202869 ()


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

STARKEY - 00842318198051

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI HS R
In Commercial Distribution

  • 00842318198051 ()


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

AUDIOSYNC - 00842318196699

No Description
Starkey Laboratories, Inc.
INTRIGUE AI 12 ITE R
In Commercial Distribution

  • 00842318196699 ()


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

AUDIOSYNC - 00842318196682

No Description
Starkey Laboratories, Inc.
INTRIGUE AI 16 ITE R
In Commercial Distribution

  • 00842318196682 ()


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

AUDIOSYNC - 00842318196675

No Description
Starkey Laboratories, Inc.
INTRIGUE AI 20 ITE R
In Commercial Distribution

  • 00842318196675 ()


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

AUDIOSYNC - 00842318196668

No Description
Starkey Laboratories, Inc.
INTRIGUE AI 24 ITE R
In Commercial Distribution

  • 00842318196668 ()


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

STARKEY - 00842318190628

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI BTE R
In Commercial Distribution

  • 00842318190628 ()


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

STARKEY - 00842318190611

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI RIC R
In Commercial Distribution

  • 00842318190611 ()


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

STARKEY - 00842318190604

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI MRIC 312
In Commercial Distribution

  • 00842318190604 ()


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

STARKEY - 00842318190598

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI BTE 13
In Commercial Distribution

  • 00842318190598 ()


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

STARKEY - 00842318190581

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI RIC 312
In Commercial Distribution

  • 00842318190581 ()


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

STARKEY - 00842318189806

No Description
Starkey Laboratories, Inc.
EVOLV AI BTE 13 (GS)
In Commercial Distribution

  • 00842318189806 ()


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

STARKEY - 00842318189790

No Description
Starkey Laboratories, Inc.
EVOLV AI BTE R (GS)
In Commercial Distribution

  • 00842318189790 ()


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

STARKEY - 00842318189776

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

  • 00842318189776 ()


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

STARKEY - 00842318189769

No Description
Starkey Laboratories, Inc.
EVOLV AI MRIC 312 (GS)
In Commercial Distribution

  • 00842318189769 ()


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

STARKEY - 00842318189745

No Description
Starkey Laboratories, Inc.
EVOLV AI RIC R (GS)
In Commercial Distribution

  • 00842318189745 ()


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

AUDIOSYNC - 00842318188267

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1000 CIC
In Commercial Distribution

  • 00842318188267 ()


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

AUDIOSYNC - 00842318188250

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1200 CIC
In Commercial Distribution

  • 00842318188250 ()


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

AUDIOSYNC - 00842318188243

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1600 CIC
In Commercial Distribution

  • 00842318188243 ()


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

AUDIOSYNC - 00842318188236

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 2000 CIC
In Commercial Distribution

  • 00842318188236 ()


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

AUDIOSYNC - 00842318188229

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 2400 CIC
In Commercial Distribution

  • 00842318188229 ()


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

MICROTECH - 00842318188168

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1000 CIC
In Commercial Distribution

  • 00842318188168 ()


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

MICROTECH - 00842318188151

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1200 CIC
In Commercial Distribution

  • 00842318188151 ()


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