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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No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI 1600 BTE R
In Commercial Distribution

  • 00842318178411 ()
63122-8

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

  • 00842318178404 ()
63212-MIC

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

  • 00842318178398 ()
63123-8

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

  • 00842318178381 ()
63213-MIC

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

  • 00842318178374 ()
63124-8

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

  • 00842318178022 ()
63209-ASY

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

  • 00842318178015 ()
63120-J, 63175-J

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

  • 00842318178008 ()
63210-ASY

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

  • 00842318177995 ()
63121-J

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

  • 00842318177988 ()
63211-ASY

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