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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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Beltone - 05708296078790

USB,FSW,BT SOLUS MAX 1.0,US
Gn Hearing A/S
20477900
In Commercial Distribution

  • 05708296078790 ()


  • Audiometric/hearing device software

Beltone - 05708296078783

DVD,FSW,BT SOLUS MAX 1.0,US
Gn Hearing A/S
20477800
In Commercial Distribution

  • 05708296078783 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078769

USB,FSW,RS SMART FIT 1.0,US
Gn Hearing A/S
20231110
In Commercial Distribution

  • 05708296078769 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078752

DVD,FSW,RS SMART FIT 1.0,US
Gn Hearing A/S
20231410
In Commercial Distribution

  • 05708296078752 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078745

DVD,FSW,AUDIGY 1.0
Gn Hearing A/S
20474200
In Commercial Distribution

  • 05708296078745 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078462

USB,FSW,RS AVENTA 3.10#2,US
Gn Hearing A/S
20473500
In Commercial Distribution

  • 05708296078462 ()


  • Audiometric/hearing device software

GN ReSound - 05708296078455

DVD,FSW,RS AVENTA 3.10#2,US
Gn Hearing A/S
20473400
In Commercial Distribution

  • 05708296078455 ()


  • Audiometric/hearing device software

Beltone - 05708296077038

SW,FSW,BT,SOLUS PRO 1.11
Gn Hearing A/S
20450300
In Commercial Distribution

  • 05708296077038 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077021

SW,FSW,RS AVENTA 3.11
Gn Hearing A/S
20450200
In Commercial Distribution

  • 05708296077021 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077014

SW,FSW,AUDIGY 1.0
Gn Hearing A/S
20449000
In Commercial Distribution

  • 05708296077014 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077007

USB,FSW,AUDIGY 1.0
Gn Hearing A/S
20448900
In Commercial Distribution

  • 05708296077007 ()


  • Audiometric/hearing device software

Beltone - 05708296076765

DVD,AIRLINK 2 UPDATE,BT
Gn Hearing A/S
20538700
In Commercial Distribution

  • 05708296076765 ()


  • Audiometric/hearing device software

GN ReSound - 05708296087907

SW,FSW,RS,AVENTA 3.12
Gn Hearing A/S
20594700
In Commercial Distribution

  • 05708296087907 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085989

DVD,FSW,SMART FIT 1.1,COSTCO
Gn Hearing A/S
20577911
In Commercial Distribution

  • 05708296085989 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085972

SW,FSW,AVENTA 3.12,COSTCO
Gn Hearing A/S
20579000
In Commercial Distribution

  • 05708296085972 ()


  • Audiometric/hearing device software

Beltone - 05708296085682

USB,FSW,BT SOLUS MAX 1.0#1,US
Gn Hearing A/S
20552610
In Commercial Distribution

  • 05708296085682 ()


  • Audiometric/hearing device software

Beltone - 05708296085675

DVD,FSW,BT SOLUS MAX 1.0#1,US
Gn Hearing A/S
20552310
In Commercial Distribution

  • 05708296085675 ()


  • Audiometric/hearing device software

Beltone - 05708296085668

USB,FSW,BT SOLUS MAX 1.0#1
Gn Hearing A/S
20552010
In Commercial Distribution

  • 05708296085668 ()


  • Audiometric/hearing device software

Beltone - 05708296085651

DVD,FSW,BT SOLUS MAX 1.0#1
Gn Hearing A/S
20551610
In Commercial Distribution

  • 05708296085651 ()


  • Audiometric/hearing device software

Beltone - 05708296085644

SW,FSW,BT SOLUS MAX 1.0#1
Gn Hearing A/S
20551700
In Commercial Distribution

  • 05708296085644 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085637

USB,FSW,RS SMART FIT 1.0#1,US
Gn Hearing A/S
20551310
In Commercial Distribution

  • 05708296085637 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085620

DVD,FSW,RS SMART FIT 1.0#1,US
Gn Hearing A/S
20551010
In Commercial Distribution

  • 05708296085620 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085613

USB,FSW,RS SMART FIT 1.0#1
Gn Hearing A/S
20550710
In Commercial Distribution

  • 05708296085613 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085606

DVD,FSW,RS SMART FIT 1.0#1
Gn Hearing A/S
20550410
In Commercial Distribution

  • 05708296085606 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085590

SW,FSW,RS SMART FIT 1.0#1
Gn Hearing A/S
20550300
In Commercial Distribution

  • 05708296085590 ()


  • Audiometric/hearing device software

Beltone - 05708296085569

DVD,FSW,BT SOLUS MAX 1.1
Gn Hearing A/S
20523611
In Commercial Distribution

  • 05708296085569 ()


  • Audiometric/hearing device software

Beltone - 05708296085552

SW,FSW,BT SOLUS MAX 1.1
Gn Hearing A/S
20523900
In Commercial Distribution

  • 05708296085552 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085538

DVD,FSW,RS SMART FIT 1.1
Gn Hearing A/S
20523011
In Commercial Distribution

  • 05708296085538 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085514

DVD,FSW,RS SMART FIT 1.1,VA
Gn Hearing A/S
20522111
In Commercial Distribution

  • 05708296085514 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085507

USB,FSW,RS SMART FIT 1.1,US
Gn Hearing A/S
20521611
In Commercial Distribution

  • 05708296085507 ()


  • Audiometric/hearing device software
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