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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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Hansaton scout 5.5
Sonova AG
058-5237-055
In Commercial Distribution

  • 07613389662481 ()
058-5237-055

  • Audiometric/hearing device software
Aura:fit 5.5
Sonova AG
058-5180-055
In Commercial Distribution

  • 07613389662474 ()
058-5180-055

  • Audiometric/hearing device software
Unitron TrueFit 5.5
Sonova AG
058-5178-055
In Commercial Distribution

  • 07613389662467 ()
058-5178-055

  • Audiometric/hearing device software
No Description
Advanced Bionics AG
CI-6055-010
Not in Commercial Distribution

  • 07630016842566 ()
  • 07630016826382 ()


  • Audiometric/hearing device software
2.2.25
Advanced Bionics, LLC
CI-6055-008
Not in Commercial Distribution

  • 07630016816925 ()


  • Audiometric/hearing device software
No Description
Advanced Bionics, LLC
AB-6052CD
Not in Commercial Distribution

  • 07630016804335 ()


  • Audiometric/hearing device software
No Description
Roche Molecular Systems, Inc.
09342311001
In Commercial Distribution

  • 07613336193341 ()
09342311001

  • Self-care monitoring/reporting software
No Description
Roche Molecular Systems, Inc.
09342290001
In Commercial Distribution

  • 07613336193334 ()
09342290001

  • Self-care monitoring/reporting software
No Description
Roche Molecular Systems, Inc.
09341935001
In Commercial Distribution

  • 07613336193297 ()
09341935001

  • Self-care monitoring/reporting software
No Description
Roche Molecular Systems, Inc.
09341927001
In Commercial Distribution

  • 07613336193280 ()
09341927001

  • Self-care monitoring/reporting software
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