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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COMPASS GPS V2.5 package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069684438 ()
7 503 0122 002

  • Audiometric/hearing device software
COMPASS GPS V2.5 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069684421 ()
7 503 0122 001

  • Audiometric/hearing device software
Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software
Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software
COMPASS GPS V2.3 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069656398 ()
7 503 0116 001

  • Audiometric/hearing device software
COMPASS GPS V2.2, USB plug
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069647280 ()
9 503 0849 000

  • Audiometric/hearing device software
COMPASS GPS V2.2 package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069645927 ()
7 503 0113 004

  • Audiometric/hearing device software
COMPASS GPS V2.2 package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069645903 ()
7 503 0113 002

  • Audiometric/hearing device software
Compass V5.9.1 CD-ROM
Widex A/S
COMPASS
In Commercial Distribution

  • 05706069593907 ()
9 512 0056 100

  • Audiometric/hearing device software
COMPASS GPS V2.0 package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069588125 ()
7 503 0110 004

  • Audiometric/hearing device software
COMPASS GPS V2.0 package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069588118 ()
7 503 0110 003

  • Audiometric/hearing device software
COMPASS GPS V2.0 package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069588101 ()
7 503 0110 002

  • Audiometric/hearing device software
COMPASS GPS V2.0 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069588095 ()
7 503 0110 001

  • Audiometric/hearing device software
GENIE 2 2019.2 AGX HEARING
Oticon A/S
204675
In Commercial Distribution

  • 05707131357847 ()


  • Audiometric/hearing device software
GENIE 2 2019.2 VA
Oticon A/S
204671
In Commercial Distribution

  • 05707131357809 ()


  • Audiometric/hearing device software
GENIE 2 2019.2 OTICON
Oticon A/S
204670
In Commercial Distribution

  • 05707131357793 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2019.1 AGX HEARING
Oticon A/S
196708
In Commercial Distribution

  • 05707131345837 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2 2019.1 AVADA
Oticon A/S
196707
In Commercial Distribution

  • 05707131345820 ()


  • Audiometric/hearing device software
GENIE 2 2019.1 OTICON VA
Oticon A/S
196704
In Commercial Distribution

  • 05707131345790 ()


  • Audiometric/hearing device software
GENIE 2 2019.1 OTICON
Oticon A/S
196703
In Commercial Distribution

  • 05707131345783 ()


  • Audiometric/hearing device software
AMPLIFON GENIE 2, 2018.2 AMPLIFON
Oticon A/S
193881
In Commercial Distribution

  • 05707131343949 ()


  • Audiometric/hearing device software
GENIE 2 2018.2 OTICON
Oticon A/S
190057
In Commercial Distribution

  • 05707131339362 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2018.2 AGX HEARING
Oticon A/S
190064
In Commercial Distribution

  • 05707131339355 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2 2018.2 AVADA
Oticon A/S
190062
In Commercial Distribution

  • 05707131339348 ()


  • Audiometric/hearing device software
GENIE 2 2018.2 AUDIKA
Oticon A/S
190059
In Commercial Distribution

  • 05707131339324 ()


  • Audiometric/hearing device software
GENIE 2 2018.2 OTICON VA
Oticon A/S
190058
In Commercial Distribution

  • 05707131339317 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2017.2 AGX HEARING US
Oticon A/S
185799
In Commercial Distribution

  • 05707131335142 ()


  • Audiometric/hearing device software
GENIE 2 2017.2 VA US
Oticon A/S
185798
In Commercial Distribution

  • 05707131335135 ()


  • Audiometric/hearing device software
GENIE 2 2017.2
Oticon A/S
185795
In Commercial Distribution

  • 05707131335104 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2 2017.2 AVADA US
Oticon A/S
185794
In Commercial Distribution

  • 05707131335098 ()


  • Audiometric/hearing device software
GENIE 2016.2 NHS
Oticon A/S
183832
In Commercial Distribution

  • 05707131332172 ()


  • Audiometric/hearing device software
SELECTIC/NOVASENSE 2 2017.1
Oticon A/S
181798
In Commercial Distribution

  • 05707131330994 ()


  • Audiometric/hearing device software
SELECTIC/NOVASENSE 2017.1
Oticon A/S
181797
In Commercial Distribution

  • 05707131330987 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2 2017.1
Oticon A/S
181796
In Commercial Distribution

  • 05707131330970 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2017.1
Oticon A/S
181795
In Commercial Distribution

  • 05707131330963 ()


  • Audiometric/hearing device software
GENIE 2 VA 2017.1
Oticon A/S
181788
In Commercial Distribution

  • 05707131330932 ()


  • Audiometric/hearing device software
GENIE 2 2017.1
Oticon A/S
181787
In Commercial Distribution

  • 05707131330925 ()


  • Audiometric/hearing device software
GENIE VA 2017.1
Oticon A/S
181786
In Commercial Distribution

  • 05707131330918 ()


  • Audiometric/hearing device software
GENIE 2017.1
Oticon A/S
181785
In Commercial Distribution

  • 05707131330901 ()


  • Audiometric/hearing device software
AUDIKA GENIE 2 2017.1
Oticon A/S
181782
In Commercial Distribution

  • 05707131330895 ()


  • Audiometric/hearing device software
AUDIKA GENIE 2017.1
Oticon A/S
181781
In Commercial Distribution

  • 05707131330888 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2017.1
Oticon A/S
181780
In Commercial Distribution

  • 05707131330871 ()


  • Audiometric/hearing device software
AUDIGYFIT 2017.1
Oticon A/S
181779
In Commercial Distribution

  • 05707131330864 ()


  • Audiometric/hearing device software
COMPASS GPS 3.3 SP1 DVD Package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069890860 ()
7 503 0139 001

  • Audiometric/hearing device software
COMPASS GPS 3.4 DVD VA package
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069887860 ()
7 503 0138 001

  • Audiometric/hearing device software
COMPASS GPS 3.4 DVD package (Spanish)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069887839 ()
7 503 0137 004

  • Audiometric/hearing device software
COMPASS GPS 3.4 DVD package (French)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069887822 ()
7 503 0137 003

  • Audiometric/hearing device software
COMPASS GPS 3.4 DVD package (German)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069887815 ()
7 503 0137 002

  • Audiometric/hearing device software
COMPASS GPS 3.4 DVD package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069887808 ()
7 503 0137 001

  • Audiometric/hearing device software
COMPASS GPS 3.3 VA DVD Package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069858518 ()
7 503 0136 001

  • Audiometric/hearing device software
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