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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.
AMPLIFON AMPLI-ENERGY R 3|6S R-S ST
In Commercial Distribution

  • 00840388203880 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
AUDIOSYNC EDGE AI MRIC R
In Commercial Distribution

  • 00840388203873 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
STARKEY LABORATORIES, INC.
AUDIBEL VITALITY AI MRIC R
In Commercial Distribution

  • 00840388203866 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
STARKEY EVOLV AI BTE R
In Commercial Distribution

  • 00842318190628 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
STARKEY EVOLV AI RIC R
In Commercial Distribution

  • 00842318190611 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
STARKEY EVOLV AI MRIC 312
In Commercial Distribution

  • 00842318190604 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
STARKEY EVOLV AI BTE 13
In Commercial Distribution

  • 00842318190598 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
STARKEY LABORATORIES, INC.
STARKEY EVOLV AI RIC 312
In Commercial Distribution

  • 00842318190581 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
STARKEY LABORATORIES, INC.
STARKEY EVOLV AI POWER PLUS BTE 13
In Commercial Distribution

  • 00842318190574 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
(DEMO) AUDIOSYNC ARC AI 2400 BTE R
In Commercial Distribution

  • 00842318190314 ()


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