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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.
STARKEY EVOLV AI 2400 POWER PLUS BTE 13
In Commercial Distribution

  • 00842318187376 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO T.5 AI BTE 13
In Commercial Distribution

  • 00842318179135 ()
63113-E

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 9.5 AI RIC R (Right)
In Commercial Distribution

  • 00842318179128 ()
63040-E

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 9.5 AI MRIC 312 (Right)
In Commercial Distribution

  • 00842318179111 ()
63046-E

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 3.5 AI RIC R (Right)
In Commercial Distribution

  • 00842318179098 ()
63042-E

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 3.5 AI MRIC 312 (Right)
In Commercial Distribution

  • 00842318179081 ()
63048-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 2.5 AI RIC R (Right)
In Commercial Distribution

  • 00842318179050 ()
63043-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 2.5 AI RIC 312 (Right)
In Commercial Distribution

  • 00842318179043 ()
63084-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 11.6 AI RIC R (Left)
In Commercial Distribution

  • 00842318179012 ()
63194-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 11.6 AI MRIC 312 (Right)
In Commercial Distribution

  • 00842318179005 ()
63193-E

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