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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SOFTWARE CONNEXX 9.8
Ws Audiology Usa, Inc.
Connexx 9.8
In Commercial Distribution

  • 05714880169393 ()
21016993

  • Audiometric/hearing device software
SOFTWARE COMPASS CLOUD
Widex A/S
Widex Compass Cloud
In Commercial Distribution

  • 05714880207750 ()
21028348

  • Audiometric/hearing device software
SOFTWARE CONNEXX 9.11
Ws Audiology Usa, Inc.
Connexx 9.11
In Commercial Distribution

  • 05714880200003 ()
21026507

  • Audiometric/hearing device software
TrueFit Software v5.4
Sonova AG
058-5178-054
In Commercial Distribution

  • 07613389644579 ()
058-5178-054

  • Audiometric/hearing device software
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software
Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52275
Not in Commercial Distribution

  • 09008737522759 ()


  • Audiometric/hearing device software
Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38208
In Commercial Distribution

  • 09008737382087 ()


  • Audiometric/hearing device software
Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36363
In Commercial Distribution

  • 09008737363635 ()


  • Audiometric/hearing device software
SOFTWARE CD S0278-00 FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169719972 ()


  • Audiometric/hearing device software
SOFTWARE C-TUNE II 4.7
Widex A/S
C-Tune II 4.7
In Commercial Distribution

  • 05714880239171 ()
21038007

  • Audiometric/hearing device software
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