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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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HANSATON - 07613389143232

USB V3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5227
In Commercial Distribution

  • 07613389143232 ()
058-5227

  • Audiometric/hearing device software

HANSATON - 07613389143225

DVD v3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5226
In Commercial Distribution

  • 07613389143225 ()
058-5226

  • Audiometric/hearing device software

Earlens Fitting Software, USB - 00850013007295

Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF002
Not in Commercial Distribution

  • 00850013007295 ()
ELF002

  • Audiometric/hearing device software

Earlens ELF USB - 00850013007042

Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software

Earlens ELF USB - 08500130070192

Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 3.2 ENGLISH (US) - 09321502020480

CUSTOM SOUND SUITE 3.2 ENGLISH (US)
COCHLEAR LIMITED
Z274923
In Commercial Distribution

  • 09321502020480 ()
Z274923

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 3.1 ENGLISH (US) - 09321502019873

CUSTOM SOUND SUITE 3.1 ENGLISH (US)
COCHLEAR LIMITED
Z248940
In Commercial Distribution

  • 09321502019873 ()
Z248940

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 2.0 SR2 US ENGLISH - 09321502018913

CUSTOM SOUND SUITE 2.0 SR2 US ENGLISH
COCHLEAR LIMITED
Z229456
In Commercial Distribution

  • 09321502018913 ()
Z229456

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 3.0 US ENGLISH - 09321502018906

CUSTOM SOUND SUITE 3.0 US ENGLISH
COCHLEAR LIMITED
Z220129
In Commercial Distribution

  • 09321502018906 ()
Z220129

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 2.0 SR1 FRENCH - 09321502011921

CUSTOM SOUND SUITE 2.0 SR1 FRENCH
COCHLEAR LIMITED
Z194952
In Commercial Distribution

  • 09321502011921 ()
Z194952

  • Audiometric/hearing device software
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