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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 - 00842318185020

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 1600 RIC R
In Commercial Distribution

  • 00842318185020 ()


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

STARKEY - 00842318185013

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 2000 RIC R
In Commercial Distribution

  • 00842318185013 ()


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

STARKEY - 00842318185006

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 2400 RIC R
In Commercial Distribution

  • 00842318185006 ()


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

AUDIOSYNC - 00842318184986

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1000 MRIC 312
In Commercial Distribution

  • 00842318184986 ()


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

AUDIOSYNC - 00842318184979

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1200 MRIC 312
In Commercial Distribution

  • 00842318184979 ()


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

AUDIOSYNC - 00842318184962

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1600 MRIC 312
In Commercial Distribution

  • 00842318184962 ()


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

AUDIOSYNC - 00842318184955

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 2000 MRIC 312
In Commercial Distribution

  • 00842318184955 ()


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

AUDIOSYNC - 00842318184948

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 2400 MRIC 312
In Commercial Distribution

  • 00842318184948 ()


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

MICROTECH - 00842318184870

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1000 MRIC 312
In Commercial Distribution

  • 00842318184870 ()


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

MICROTECH - 00842318184863

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1200 MRIC 312
In Commercial Distribution

  • 00842318184863 ()


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

MICROTECH - 00842318184856

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1600 MRIC 312
In Commercial Distribution

  • 00842318184856 ()


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

MICROTECH - 00842318184849

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 2000 MRIC 312
In Commercial Distribution

  • 00842318184849 ()


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

MICROTECH - 00842318184832

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 2400 MRIC 312
In Commercial Distribution

  • 00842318184832 ()


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

NUEAR - 00842318184818

No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 1000 MRIC 312
In Commercial Distribution

  • 00842318184818 ()


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

NUEAR - 00842318184801

No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 1200 MRIC 312
In Commercial Distribution

  • 00842318184801 ()


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

NUEAR - 00842318184795

No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 1600 MRIC 312
In Commercial Distribution

  • 00842318184795 ()


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

NUEAR - 00842318184788

No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 2000 MRIC 312
In Commercial Distribution

  • 00842318184788 ()


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

NUEAR - 00842318184771

No Description
Starkey Laboratories, Inc.
NUEAR SAVANT AI 2400 MRIC 312
In Commercial Distribution

  • 00842318184771 ()


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

AUDIBEL - 00842318184757

No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 1000 MRIC 312
In Commercial Distribution

  • 00842318184757 ()


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

AUDIBEL - 00842318184740

No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 1200 MRIC 312
In Commercial Distribution

  • 00842318184740 ()


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

AUDIBEL - 00842318184733

No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 1600 MRIC 312
In Commercial Distribution

  • 00842318184733 ()


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

AUDIBEL - 00842318184726

No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 2000 MRIC 312
In Commercial Distribution

  • 00842318184726 ()


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

AUDIBEL - 00842318184719

No Description
Starkey Laboratories, Inc.
AUDIBEL ARC AI 2400 MRIC 312
In Commercial Distribution

  • 00842318184719 ()


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

STARKEY - 00842318184696

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 1000 MRIC 312
In Commercial Distribution

  • 00842318184696 ()


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

STARKEY - 00842318184689

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 1200 MRIC 312
In Commercial Distribution

  • 00842318184689 ()


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

STARKEY - 00842318184672

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 1600 MRIC 312
In Commercial Distribution

  • 00842318184672 ()


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

STARKEY - 00842318184665

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 2000 MRIC 312
In Commercial Distribution

  • 00842318184665 ()


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

STARKEY - 00842318184658

No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI 2400 MRIC 312
In Commercial Distribution

  • 00842318184658 ()


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

AUDIOSYNC - 00842318184634

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI CROS BTE 13
In Commercial Distribution

  • 00842318184634 ()


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

AUDIOSYNC - 00842318184627

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1000 BTE 13
In Commercial Distribution

  • 00842318184627 ()


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

AUDIOSYNC - 00842318184610

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1200 BTE 13
In Commercial Distribution

  • 00842318184610 ()


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

AUDIOSYNC - 00842318184603

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 1600 BTE 13
In Commercial Distribution

  • 00842318184603 ()


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

AUDIOSYNC - 00842318184597

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 2000 BTE 13
In Commercial Distribution

  • 00842318184597 ()


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

AUDIOSYNC - 00842318184580

No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 2400 BTE 13
In Commercial Distribution

  • 00842318184580 ()


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

MICROTECH - 00842318184504

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI CROS BTE 13
In Commercial Distribution

  • 00842318184504 ()


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

MICROTECH - 00842318184498

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1000 BTE 13
In Commercial Distribution

  • 00842318184498 ()


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

MICROTECH - 00842318184481

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1200 BTE 13
In Commercial Distribution

  • 00842318184481 ()


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

MICROTECH - 00842318184474

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1600 BTE 13
In Commercial Distribution

  • 00842318184474 ()


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

MICROTECH - 00842318184467

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 2000 BTE 13
In Commercial Distribution

  • 00842318184467 ()


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

MICROTECH - 00842318184450

No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 2400 BTE 13
In Commercial Distribution

  • 00842318184450 ()


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