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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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AUDIOSYNC - 00842318190130

No Description
Starkey Laboratories, Inc.
(DEMO) AUDIOSYNC ARC AI 2400 MRIC 312
In Commercial Distribution

  • 00842318190130 ()


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

MICROTECH - 00842318190123

No Description
Starkey Laboratories, Inc.
(DEMO) MICROTECH ENVY AI 2400 MRIC 312
In Commercial Distribution

  • 00842318190123 ()


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

NUEAR - 00842318190116

No Description
Starkey Laboratories, Inc.
(DEMO) NUEAR SAVANT AI 2400 MRIC 312
In Commercial Distribution

  • 00842318190116 ()


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

AUDIBEL - 00842318190109

No Description
Starkey Laboratories, Inc.
(DEMO) AUDIBEL ARC AI 2400 MRIC 312
In Commercial Distribution

  • 00842318190109 ()


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

STARKEY - 00842318190093

No Description
Starkey Laboratories, Inc.
(DEMO) STARKEY EVOLV AI 2400 MRIC 312
In Commercial Distribution

  • 00842318190093 ()


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

NUEAR - 00842318190055

No Description
Starkey Laboratories, Inc.
(TIER DEMO) NUEAR SAVANT AI BTE 13
In Commercial Distribution

  • 00842318190055 ()


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

AUDIBEL - 00842318190048

No Description
Starkey Laboratories, Inc.
(TIER DEMO) AUDIBEL ARC AI BTE 13
In Commercial Distribution

  • 00842318190048 ()


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

AUDIOSYNC - 00842318190000

No Description
Starkey Laboratories, Inc.
(DEMO) AUDIOSYNC ARC AI 2400 BTE 13
In Commercial Distribution

  • 00842318190000 ()


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

MICROTECH - 00842318189998

No Description
Starkey Laboratories, Inc.
(DEMO) MICROTECH ENVY AI 2400 BTE 13
In Commercial Distribution

  • 00842318189998 ()


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

NUEAR - 00842318189981

No Description
Starkey Laboratories, Inc.
(DEMO) NUEAR SAVANT AI 2400 BTE 13
In Commercial Distribution

  • 00842318189981 ()


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

AUDIBEL - 00842318189974

No Description
Starkey Laboratories, Inc.
(DEMO) AUDIBEL ARC AI 2400 BTE 13
In Commercial Distribution

  • 00842318189974 ()


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

STARKEY - 00842318189967

No Description
Starkey Laboratories, Inc.
(DEMO) STARKEY EVOLV AI 2400 BTE 13
In Commercial Distribution

  • 00842318189967 ()


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

AUDIOSYNC - 00842318189950

No Description
Starkey Laboratories, Inc.
(DEMO) AUDIOSYNC ARC AI 2400 RIC 312
In Commercial Distribution

  • 00842318189950 ()


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

MICROTECH - 00842318189936

No Description
Starkey Laboratories, Inc.
(DEMO) MICROTECH ENVY AI 2400 RIC 312
In Commercial Distribution

  • 00842318189936 ()


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

NUEAR - 00842318189929

No Description
Starkey Laboratories, Inc.
(DEMO) NUEAR SAVANT AI 2400 RIC 312
In Commercial Distribution

  • 00842318189929 ()


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

AUDIBEL - 00842318189912

No Description
Starkey Laboratories, Inc.
(DEMO) AUDIBEL ARC AI 2400 RIC 312
In Commercial Distribution

  • 00842318189912 ()


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

STARKEY - 00842318189905

No Description
Starkey Laboratories, Inc.
(DEMO) STARKEY EVOLV AI 2400 RIC 312
In Commercial Distribution

  • 00842318189905 ()


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

STARKEY - 00842318189820

No Description
Starkey Laboratories, Inc.
EVOLV AI POWER PLUS BTE 13 (GS)
In Commercial Distribution

  • 00842318189820 ()


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

AUDIGY - 00842318188045

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1000 MRIC 312
In Commercial Distribution

  • 00842318188045 ()


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

AUDIGY - 00842318188038

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1200 MRIC 312
In Commercial Distribution

  • 00842318188038 ()


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

AUDIGY - 00842318188021

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1600 MRIC 312
In Commercial Distribution

  • 00842318188021 ()


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

AUDIGY - 00842318188014

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2000 MRIC 312
In Commercial Distribution

  • 00842318188014 ()


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

AUDIGY - 00842318188007

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 MRIC 312
In Commercial Distribution

  • 00842318188007 ()


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

AUDIGY - 00842318187284

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1600 IIC NW
In Commercial Distribution

  • 00842318187284 ()


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

AUDIGY - 00842318187277

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2000 IIC NW
In Commercial Distribution

  • 00842318187277 ()


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

AUDIGY - 00842318187260

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 IIC NW
In Commercial Distribution

  • 00842318187260 ()


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

AUDIGY - 00842318186997

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1000 CIC NW
In Commercial Distribution

  • 00842318186997 ()


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

AUDIGY - 00842318186980

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1200 CIC NW
In Commercial Distribution

  • 00842318186980 ()


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

AUDIGY - 00842318186973

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1600 CIC NW
In Commercial Distribution

  • 00842318186973 ()


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

AUDIGY - 00842318186966

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2000 CIC NW
In Commercial Distribution

  • 00842318186966 ()


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

AUDIGY - 00842318186959

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 CIC NW
In Commercial Distribution

  • 00842318186959 ()


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

AUDIGY - 00842318186676

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1000 ITE R
In Commercial Distribution

  • 00842318186676 ()


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

AUDIGY - 00842318186669

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1200 ITE R
In Commercial Distribution

  • 00842318186669 ()


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

AUDIGY - 00842318186652

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1600 ITE R
In Commercial Distribution

  • 00842318186652 ()


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

AUDIGY - 00842318186645

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2000 ITE R
In Commercial Distribution

  • 00842318186645 ()


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

AUDIGY - 00842318186638

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 ITE R
In Commercial Distribution

  • 00842318186638 ()


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

AUDIGY - 00842318186379

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

  • 00842318186379 ()


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

AUDIGY - 00842318186362

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

  • 00842318186362 ()


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

AUDIGY - 00842318186355

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

  • 00842318186355 ()


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

AUDIGY - 00842318186348

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

  • 00842318186348 ()


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