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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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PHONAK - 07613389120035

Phonak Target 5.4 DVD
Sonova AG
058-0125-054
In Commercial Distribution

  • 07613389120035 ()
058-0125-054

  • Audiometric/hearing device software

Phonak - 07613389082623

myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software

UNITRON - 07613389075823

Unitron Remote Plus app
Unitron Hearing Division
088-5001
In Commercial Distribution

  • 07613389075823 ()
088-5001

  • Audiometric/hearing device software

PHONAK - 07613389003772

Phonak Target 5.3 DVD
Sonova AG
058-0125-053
In Commercial Distribution

  • 07613389003772 ()
058-0125-053

  • Audiometric/hearing device software

Sonova - 07613389310979

myPhonak app
Sonova AG
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software

Sonova - 07613389310962

Easy Line remote App
Sonova AG
088-0010
In Commercial Distribution

  • 07613389310962 ()
088-0010

  • Audiometric/hearing device software

Phonak - 07613389308778

Phonak Target 6.1 DVD
Sonova AG
058-0125-061
In Commercial Distribution

  • 07613389308778 ()
058-0125-061

  • Audiometric/hearing device software

NOVA Basic - B057U40140

The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.8
In Commercial Distribution

  • B057U40140 ()
U4 014

  • Stereotactic system application software

NOVA AR - B057U4003260170

The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.17
In Commercial Distribution

  • B057U4003260170 ()
U4 003

  • Stereotactic system application software

NOVA AR - B057U4003260160

The Navigation Software NOCA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.16
In Commercial Distribution

  • B057U4003260160 ()
U4 003

  • Stereotactic system application software
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