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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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Cochlear - 09321502044899

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1341442
In Commercial Distribution

  • 09321502044899 ()
P1341442

  • Audiometric/hearing device software

Unitron - 07613389303292

AuraFit Fitting Software v4.x
Unitron Hearing Division
058-5236
In Commercial Distribution

  • 07613389303292 ()
058-5236

  • Audiometric/hearing device software

Unitron - 07613389303285

TrueFit Fitting Software v4.x
Unitron Hearing Division
058-5235
In Commercial Distribution

  • 07613389303285 ()
058-5235

  • Audiometric/hearing device software

WIDEX - 05714880256772

SOFTWARE COMP GPS 4.8 USB PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256772 ()
21041975

  • Audiometric/hearing device software

WIDEX - 05714880256765

SOFTWARE COMP GPS 4.8 DVD PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256765 ()
21041974

  • Audiometric/hearing device software

OTHERS - 05714880204070

SOFTWARE COMP GPS 4.5 DVD PACKAGE
Widex A/S
Compass GPS 4.5
In Commercial Distribution

  • 05714880204070 ()
21027791

  • Audiometric/hearing device software

WIDEX - 05714880239140

SOFTWARE COMP GPS 4.7 USB PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239140 ()
21038004

  • Audiometric/hearing device software

WIDEX - 05714880239133

SOFTWARE COMP GPS 4.7 DVD PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239133 ()
21038003

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502065764

Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502065757

Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
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