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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 Class Implantable

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Bernafon - 05714464013036

Bernafon OasisNxt 2021.2
Sbo Hearing A/S
228221
In Commercial Distribution

  • 05714464013036 ()


  • Audiometric/hearing device software

Neutral - 05714464013029

OasisNxt Custom 2021.2
Sbo Hearing A/S
228220
In Commercial Distribution

  • 05714464013029 ()


  • Audiometric/hearing device software

Sonic - 05714464013012

Sonic ExpressfitPro 2021.2
Sbo Hearing A/S
228219
In Commercial Distribution

  • 05714464013012 ()


  • Audiometric/hearing device software

Philips - 05714464013005

Philips HearSuite 2021.2
Sbo Hearing A/S
228218
In Commercial Distribution

  • 05714464013005 ()


  • Audiometric/hearing device software

Audigy - 05714464005895

AUDIGYFIT 2 2020.2
Sbo Hearing A/S
218087
In Commercial Distribution

  • 05714464005895 ()


  • Audiometric/hearing device software

Philips - 05714464002849

HEARSUITE 2019.2
Sbo Hearing A/S
204550
In Commercial Distribution

  • 05714464002849 ()


  • Audiometric/hearing device software

Philips - 05714464000029

HEARSUITE 2019.1
Sbo Hearing A/S
196006
In Commercial Distribution

  • 05714464000029 ()


  • Audiometric/hearing device software

Oticon - 05714464005901

OTICON GENIE 2 2020.2 VA
Sbo Hearing A/S
218088
In Commercial Distribution

  • 05714464005901 ()


  • Audiometric/hearing device software

Oticon - 05714464005840

OTICON GENIE 2 2020.2
Sbo Hearing A/S
218082
In Commercial Distribution

  • 05714464005840 ()


  • Audiometric/hearing device software

Philips - 05714464004560

PHILIPS HEARSUITE 2020.2
Sbo Hearing A/S
215180
In Commercial Distribution

  • 05714464004560 ()


  • Audiometric/hearing device software
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