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.
NUEAR CIRCA EDGE AI 2400 MRIC 312
In Commercial Distribution

  • 00842318178909 ()
63193-4, 63204-4

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
NUEAR CIRCA EDGE AI 2400 HS R
In Commercial Distribution

  • 00842318178893 ()
63208-NUE

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

  • 00842318178886 ()
63196-4, 63207-4

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
NUEAR CIRCA EDGE AI 2400 BTE 13
In Commercial Distribution

  • 00842318178879 ()
63195-4, 63203-4

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

  • 00842318178602 ()
63199-8

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA EDGE AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318178596 ()
63200-8

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA EDGE AI CROSBICROS BTE 13
In Commercial Distribution

  • 00842318178589 ()
63198-8

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA EDGE AI 2400 RIC R
In Commercial Distribution

  • 00842318178572 ()
63194-8, 63206-8

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA EDGE AI 2400 RIC 312
In Commercial Distribution

  • 00842318178565 ()
63192-8, 63205-8

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA EDGE AI 2400 MRIC 312
In Commercial Distribution

  • 00842318178558 ()
63193-8, 63204-8

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA EDGE AI 2400 HS R
In Commercial Distribution

  • 00842318178541 ()
63208-MIC

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

  • 00842318178534 ()
63196-8, 63207-8

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA EDGE AI 2400 BTE 13
In Commercial Distribution

  • 00842318178527 ()
63195-8, 63203-8

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

  • 00842318178114 ()
63199-J

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA EDGE AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318178107 ()
63200-J

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA EDGE AI CROSBICROS BTE 13
In Commercial Distribution

  • 00842318178091 ()
63198-J

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

  • 00842318178084 ()
63194-J, 63206-J

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA EDGE AI 2400 RIC 312
In Commercial Distribution

  • 00842318178077 ()
63192-J, 63205-J

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA EDGE AI 2400 MRIC 312
In Commercial Distribution

  • 00842318178060 ()
63193-J, 63204-J

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

  • 00842318178053 ()
63208-ASY

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

  • 00842318178046 ()
63196-J, 63207-J

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA EDGE AI 2400 BTE 13
In Commercial Distribution

  • 00842318178039 ()
63195-J, 63203-J

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV EDGE AI CROSBICROS RIC R
In Commercial Distribution

  • 00842318177827 ()
63199-A

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV EDGE AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318177810 ()
63200-A

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV EDGE AI CROSBICROS BTE 13
In Commercial Distribution

  • 00842318177803 ()
63198-A

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

  • 00842318177797 ()
63194-A

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV EDGE AI 2400 RIC 312
In Commercial Distribution

  • 00842318177780 ()
63192-A

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV EDGE AI 2400 MRIC 312
In Commercial Distribution

  • 00842318177773 ()
63193-A

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV EDGE AI 2400 HS R
In Commercial Distribution

  • 00842318177766 ()
63208-AUY

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

  • 00842318177759 ()
63196-A

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV EDGE AI 2400 BTE 13
In Commercial Distribution

  • 00842318177742 ()
63195-A

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AudioSync A Series AI 16 RIC R
In Commercial Distribution

  • 00840388209967 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Audigy AGXs G Series AI RIC R
In Commercial Distribution

  • 00840388209905 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AudioSync A Series AI 10 RIC R
In Commercial Distribution

  • 00840388209868 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
NuEar NE Series AI 10 RIC R
In Commercial Distribution

  • 00840388209837 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AudioSync A Series AI 12 RIC R
In Commercial Distribution

  • 00840388209790 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
NuEar NE Series AI 12 RIC R
In Commercial Distribution

  • 00840388209752 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
NuEar NE Series AI 16 RIC R
In Commercial Distribution

  • 00840388209691 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Starkey G Series AI 16 RIC R
In Commercial Distribution

  • 00840388209653 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Starkey G Series AI 16 RIC R
In Commercial Distribution

  • 00840388209646 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Starkey G Series AI 16 RIC 312
In Commercial Distribution

  • 00840388209639 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
Starkey G Series AI 16 RIC 312
In Commercial Distribution

  • 00840388209622 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
Starkey G Series AI 12 RIC R
In Commercial Distribution

  • 00840388209615 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
Starkey G Series AI 12 RIC 312
In Commercial Distribution

  • 00840388209608 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Starkey G Series AI 10 RIC R
In Commercial Distribution

  • 00840388209592 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
Starkey G Series AI 10 RIC 312
In Commercial Distribution

  • 00840388209585 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
NuEar NE Series AI 16 RIC 312
In Commercial Distribution

  • 00840388209554 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
NuEar NE Series AI 16 RIC 312
In Commercial Distribution

  • 00840388209547 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
NuEar NE Series AI 12 RIC 312
In Commercial Distribution

  • 00840388209530 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
NuEar NE Series AI 10 RIC 312
In Commercial Distribution

  • 00840388209523 ()


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