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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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No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 2.5 AI BTE R
In Commercial Distribution

  • 00842318179036 ()
63124-E

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 2.5 AI BTE 13
In Commercial Distribution

  • 00842318179029 ()
63095-E

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 11.6 AI BTE R
In Commercial Distribution

  • 00842318178992 ()
63196-E

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

  • 00842318178954 ()
63199-4

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

  • 00842318178947 ()
63200-4

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

  • 00842318178930 ()
63198-4

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

  • 00842318178923 ()
63194-4, 63206-4

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

  • 00842318178916 ()
63192-4, 63205-4

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