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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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Widex Mind440 M4-X ITE (Light beige S-440 ) Telecoil
Widex A/S
M4-X
In Commercial Distribution

  • 05706069722581 ()
8 085 0100 808

  • Air-conduction hearing aid, in-the-ear
Widex Mind440 M4-X ITE (Clay brown S-440 ) Telecoil
Widex A/S
M4-X
In Commercial Distribution

  • 05706069722574 ()
8 085 0100 812

  • Air-conduction hearing aid, in-the-ear
Widex Mind440 M4-X ITE (Dark brown S-440 ) Telecoil
Widex A/S
M4-X
In Commercial Distribution

  • 05706069722567 ()
8 085 0100 853

  • Air-conduction hearing aid, in-the-ear
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex ToneLink App iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
BEYOND app iOS
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
C-Tune II
Widex A/S
C-Tune II
In Commercial Distribution

  • 05706069658125 ()
9 513 0200 000

  • Audiometric/hearing device software
TV-Controller II DEX (DEX silver )
Widex A/S
TV-Controller II
In Commercial Distribution

  • 05706069656473 ()
8 912 0700 093

  • Hearing aid enhanced audio device, telecommunication/multimedia
COMPASS GPS V2.3 package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069656428 ()
7 503 0116 004

  • Audiometric/hearing device software
COMPASS GPS V2.3 package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069656411 ()
7 503 0116 003

  • Audiometric/hearing device software
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