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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 Laboratories, Inc.
AUDIOSYNC ARC AI 1600 BTE R
In Commercial Distribution

  • 00842318185723 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 2000 BTE R
In Commercial Distribution

  • 00842318185716 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIOSYNC ARC AI 2400 BTE R
In Commercial Distribution

  • 00842318185709 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSEVO AI 1000 BTE R
In Commercial Distribution

  • 00842318185693 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSEVO AI 1200 BTE R
In Commercial Distribution

  • 00842318185686 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSEVO AI 1600 BTE R
In Commercial Distribution

  • 00842318185679 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSEVO AI 2000 BTE R
In Commercial Distribution

  • 00842318185662 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSEVO AI 2400 BTE R
In Commercial Distribution

  • 00842318185655 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1000 BTE R
In Commercial Distribution

  • 00842318185631 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
MICROTECH ENVY AI 1200 BTE R
In Commercial Distribution

  • 00842318185624 ()


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