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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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MICROTECH - 00842318186591

No Description
STARKEY LABORATORIES, INC.
MICROTECH ENVY AI 2000 ITE R
In Commercial Distribution

  • 00842318186591 ()


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

MICROTECH - 00842318186584

No Description
STARKEY LABORATORIES, INC.
MICROTECH ENVY AI 2400 ITE R
In Commercial Distribution

  • 00842318186584 ()


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

NUEAR - 00842318186577

No Description
STARKEY LABORATORIES, INC.
NUEAR SAVANT AI 1000 ITE R
In Commercial Distribution

  • 00842318186577 ()


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

NUEAR - 00842318186560

No Description
STARKEY LABORATORIES, INC.
NUEAR SAVANT AI 1200 ITE R
In Commercial Distribution

  • 00842318186560 ()


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

NUEAR - 00842318186553

No Description
STARKEY LABORATORIES, INC.
NUEAR SAVANT AI 1600 ITE R
In Commercial Distribution

  • 00842318186553 ()


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

NUEAR - 00842318186546

No Description
STARKEY LABORATORIES, INC.
NUEAR SAVANT AI 2000 ITE R
In Commercial Distribution

  • 00842318186546 ()


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

NUEAR - 00842318186539

No Description
STARKEY LABORATORIES, INC.
NUEAR SAVANT AI 2400 ITE R
In Commercial Distribution

  • 00842318186539 ()


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

AUDIBEL - 00842318186522

No Description
STARKEY LABORATORIES, INC.
AUDIBEL ARC AI 1000 ITE R
In Commercial Distribution

  • 00842318186522 ()


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

AUDIBEL - 00842318186515

No Description
STARKEY LABORATORIES, INC.
AUDIBEL ARC AI 1200 ITE R
In Commercial Distribution

  • 00842318186515 ()


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

AUDIBEL - 00842318186508

No Description
STARKEY LABORATORIES, INC.
AUDIBEL ARC AI 1600 ITE R
In Commercial Distribution

  • 00842318186508 ()


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