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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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STARKEY - 00840388202883

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI CROS RIC 312
In Commercial Distribution

  • 00840388202883 ()


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

STARKEY - 00840388202876

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 RIC 312
In Commercial Distribution

  • 00840388202876 ()


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

STARKEY - 00840388202845

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 MRIC R
In Commercial Distribution

  • 00840388202845 ()


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

STARKEY - 00840388202838

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI CROS RIC RT
In Commercial Distribution

  • 00840388202838 ()


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

STARKEY - 00840388202821

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 RIC RT
In Commercial Distribution

  • 00840388202821 ()


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

MICROTECH - 00840388201268

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI RIC 312
In Commercial Distribution

  • 00840388201268 ()


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

NUEAR - 00840388201251

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI RIC 312
In Commercial Distribution

  • 00840388201251 ()


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

MICROTECH - 00840388201220

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI MRIC R
In Commercial Distribution

  • 00840388201220 ()


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

NUEAR - 00840388201213

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI MRIC R
In Commercial Distribution

  • 00840388201213 ()


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

MICROTECH - 00840388201183

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI RIC RT
In Commercial Distribution

  • 00840388201183 ()


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

NUEAR - 00840388201176

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI RIC RT
In Commercial Distribution

  • 00840388201176 ()


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

AUDIOSYNC - 00840388200513

No Description
Starkey Laboratories, Inc.
AUDIOSYNC INTRIGUE AI CROSBICROS RIC 312
In Commercial Distribution

  • 00840388200513 ()


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

AUDIBEL - 00840388200452

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI CROSBICROS RIC 312
In Commercial Distribution

  • 00840388200452 ()


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

STARKEY - 00840388200445

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI CROSBICROS RIC 312
In Commercial Distribution

  • 00840388200445 ()


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

AUDIOSYNC - 00840388200407

No Description
Starkey Laboratories, Inc.
AUDIOSYNC INTRIGUE AI 12 RIC 312
In Commercial Distribution

  • 00840388200407 ()


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

AUDIBEL - 00840388200346

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI 12 RIC 312
In Commercial Distribution

  • 00840388200346 ()


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

STARKEY - 00840388200339

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 12 RIC 312
In Commercial Distribution

  • 00840388200339 ()


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

AUDIOSYNC - 00840388200292

No Description
Starkey Laboratories, Inc.
AUDIOSYNC INTRIGUE AI 16 RIC 312
In Commercial Distribution

  • 00840388200292 ()


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

AUDIBEL - 00840388200230

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI 16 RIC 312
In Commercial Distribution

  • 00840388200230 ()


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

STARKEY - 00840388200223

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 16 RIC 312
In Commercial Distribution

  • 00840388200223 ()


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

AUDIOSYNC - 00840388200186

No Description
Starkey Laboratories, Inc.
AUDIOSYNC INTRIGUE AI 20 RIC 312
In Commercial Distribution

  • 00840388200186 ()


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

AUDIBEL - 00840388200124

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI 20 RIC 312
In Commercial Distribution

  • 00840388200124 ()


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

STARKEY - 00840388200117

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 20 RIC 312
In Commercial Distribution

  • 00840388200117 ()


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

AUDIOSYNC - 00840388200063

No Description
Starkey Laboratories, Inc.
AUDIOSYNC INTRIGUE AI 24 RIC 312
In Commercial Distribution

  • 00840388200063 ()


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

AUDIBEL - 00840388200001

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI 24 RIC 312
In Commercial Distribution

  • 00840388200001 ()


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

AUDIGY - 00842318177681

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1600 BTE R
In Commercial Distribution

  • 00842318177681 ()
63122-A

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

AUDIGY - 00842318177674

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

  • 00842318177674 ()
63212-AUY

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

AUDIGY - 00842318177667

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1200 BTE R
In Commercial Distribution

  • 00842318177667 ()
63123-A

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

AUDIGY - 00842318177650

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

  • 00842318177650 ()
63213-AUY

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

AUDIGY - 00842318177643

No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1000 BTE R
In Commercial Distribution

  • 00842318177643 ()
63124-A

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

AUDIBEL - 00842318177360

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 2400 HS R
In Commercial Distribution

  • 00842318177360 ()
63209-ABL

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

AUDIBEL - 00842318177353

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 2000 HS R
In Commercial Distribution

  • 00842318177353 ()
63210-ABL

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

AUDIBEL - 00842318177346

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1600 HS R
In Commercial Distribution

  • 00842318177346 ()
63211-ABL

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

AUDIBEL - 00842318177339

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1200 HS R
In Commercial Distribution

  • 00842318177339 ()
63212-ABL

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

AUDIBEL - 00842318177322

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1000 HS R
In Commercial Distribution

  • 00842318177322 ()
63213-ABL

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

AUDIBEL - 00842318177216

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 2400 BTE R
In Commercial Distribution

  • 00842318177216 ()
63175-2

  • Air-conduction hearing aid, behind-the-ear

STARKEY - 00842318177209

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI 2400 BTE R
In Commercial Distribution

  • 00842318177209 ()
63175-1

  • Air-conduction hearing aid, behind-the-ear

AUDIBEL - 00842318177162

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1000 BTE R
In Commercial Distribution

  • 00842318177162 ()
63124-2

  • Air-conduction hearing aid, behind-the-ear

STARKEY - 00842318177155

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI 1000 BTE R
In Commercial Distribution

  • 00842318177155 ()
63124-1, 63124-7

  • Air-conduction hearing aid, behind-the-ear

AUDIBEL - 00842318177131

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI 1200 BTE R
In Commercial Distribution

  • 00842318177131 ()
63123-2

  • Air-conduction hearing aid, behind-the-ear
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