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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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Hyperfine Operations, Inc.
Version 1.0
In Commercial Distribution

  • 00860000606189 ()


  • Image segmentation application software
REMI-Cloud
Epitel, Inc.
2.3
Not in Commercial Distribution

  • 00860005388158 ()


  • Bioelectrical signal analysis software
Oticon Genie 2 2021.2
Sbo Hearing A/S
228229
In Commercial Distribution

  • 05714464013104 ()


  • Audiometric/hearing device software
Oticon Genie 2 2021.2 VA
Sbo Hearing A/S
228227
In Commercial Distribution

  • 05714464013081 ()


  • Audiometric/hearing device software
AudigyFit 2 2021.2
Sbo Hearing A/S
228223
In Commercial Distribution

  • 05714464013043 ()


  • Audiometric/hearing device software
Bernafon OasisNxt 2021.2
Sbo Hearing A/S
228221
In Commercial Distribution

  • 05714464013036 ()


  • Audiometric/hearing device software
OasisNxt Custom 2021.2
Sbo Hearing A/S
228220
In Commercial Distribution

  • 05714464013029 ()


  • Audiometric/hearing device software
Sonic ExpressfitPro 2021.2
Sbo Hearing A/S
228219
In Commercial Distribution

  • 05714464013012 ()


  • Audiometric/hearing device software
Philips HearSuite 2021.2
Sbo Hearing A/S
228218
In Commercial Distribution

  • 05714464013005 ()


  • Audiometric/hearing device software
OTICON GENIE 2 2020.2 VA
Sbo Hearing A/S
218088
In Commercial Distribution

  • 05714464005901 ()


  • Audiometric/hearing device software
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