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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 - 00842318178466

No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI 2400 HS R
In Commercial Distribution

  • 00842318178466 ()
63209-MIC

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

MICROTECH - 00842318178459

No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI 2400 BTE R
In Commercial Distribution

  • 00842318178459 ()
63120-8, 63175-8

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

MICROTECH - 00842318178442

No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI 2000 HS R
In Commercial Distribution

  • 00842318178442 ()
63210-MIC

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

MICROTECH - 00842318178435

No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI 2000 BTE R
In Commercial Distribution

  • 00842318178435 ()
63121-8

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

MICROTECH - 00842318178428

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

  • 00842318178428 ()
63211-MIC

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

MICROTECH - 00842318178411

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

MICROTECH - 00842318178404

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

MICROTECH - 00842318178398

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

MICROTECH - 00842318178381

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

MICROTECH - 00842318178374

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

AUDIOSYNC - 00842318178022

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

AUDIOSYNC - 00842318178015

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

AUDIOSYNC - 00842318178008

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

AUDIOSYNC - 00842318177995

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

AUDIOSYNC - 00842318177988

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

AUDIOSYNC - 00842318177971

No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI 1600 BTE R
In Commercial Distribution

  • 00842318177971 ()
63122-J

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

AUDIOSYNC - 00842318177964

No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI 1200 HS R
In Commercial Distribution

  • 00842318177964 ()
63212-ASY

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

AUDIOSYNC - 00842318177957

No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI 1200 BTE R
In Commercial Distribution

  • 00842318177957 ()
63123-J

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

AUDIOSYNC - 00842318177940

No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI 1000 HS R
In Commercial Distribution

  • 00842318177940 ()
63213-ASY

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

AUDIOSYNC - 00842318177933

No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI 1000 BTE R
In Commercial Distribution

  • 00842318177933 ()
63124-J

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

AUDIGY - 00842318177735

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 2400 HS R
In Commercial Distribution

  • 00842318177735 ()
63209-AUY

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

AUDIGY - 00842318177728

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 2400 BTE R
In Commercial Distribution

  • 00842318177728 ()
63120-A

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

AUDIGY - 00842318177711

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 2000 HS R
In Commercial Distribution

  • 00842318177711 ()
63210-AUY

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

AUDIGY - 00842318177704

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 2000 BTE R
In Commercial Distribution

  • 00842318177704 ()
63121-A

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

AUDIGY - 00842318177698

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1600 HS R
In Commercial Distribution

  • 00842318177698 ()
63211-AUY

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

AUDIGY - 00842318177681

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1600 BTE R
In Commercial Distribution

  • 00842318177681 ()
63122-A

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

AUDIGY - 00842318177674

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1200 HS R
In Commercial Distribution

  • 00842318177674 ()
63212-AUY

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

AUDIGY - 00842318177667

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1200 BTE R
In Commercial Distribution

  • 00842318177667 ()
63123-A

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

AUDIGY - 00842318177650

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1000 HS R
In Commercial Distribution

  • 00842318177650 ()
63213-AUY

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

AUDIGY - 00842318177643

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1000 BTE R
In Commercial Distribution

  • 00842318177643 ()
63124-A

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

AUDIBEL - 00842318177360

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 2400 HS R
In Commercial Distribution

  • 00842318177360 ()
63209-ABL

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

AUDIBEL - 00842318177353

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 2000 HS R
In Commercial Distribution

  • 00842318177353 ()
63210-ABL

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

AUDIBEL - 00842318177346

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1600 HS R
In Commercial Distribution

  • 00842318177346 ()
63211-ABL

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

AUDIBEL - 00842318177339

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1200 HS R
In Commercial Distribution

  • 00842318177339 ()
63212-ABL

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

AUDIBEL - 00842318177322

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1000 HS R
In Commercial Distribution

  • 00842318177322 ()
63213-ABL

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

AUDIBEL - 00842318177216

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 2400 BTE R
In Commercial Distribution

  • 00842318177216 ()
63175-2

  • Air-conduction hearing aid, behind-the-ear

STARKEY - 00842318177209

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI 2400 BTE R
In Commercial Distribution

  • 00842318177209 ()
63175-1

  • Air-conduction hearing aid, behind-the-ear

AUDIBEL - 00842318177162

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1000 BTE R
In Commercial Distribution

  • 00842318177162 ()
63124-2

  • Air-conduction hearing aid, behind-the-ear

STARKEY - 00842318177155

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI 1000 BTE R
In Commercial Distribution

  • 00842318177155 ()
63124-1, 63124-7

  • Air-conduction hearing aid, behind-the-ear

AUDIBEL - 00842318177131

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1200 BTE R
In Commercial Distribution

  • 00842318177131 ()
63123-2

  • Air-conduction hearing aid, behind-the-ear
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