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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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UltraSPECT - 00850040177077

WBR Imaging X + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177077 ()


  • SPECT system application software

UltraSPECT - 00850040177060

WBR Imaging X + X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177060 ()


  • SPECT system application software

UltraSPECT - 00850040177053

WBR Imaging X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177053 ()


  • SPECT system application software

UltraSPECT - 00850040177046

WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177046 ()


  • SPECT system application software

UltraSPECT - 00850040177039

WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177039 ()


  • SPECT system application software

UltraSPECT - 00850040177022

WBR Imaging X + X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177022 ()


  • SPECT system application software

UltraSPECT - 00850040177015

WBR Imaging X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177015 ()


  • SPECT system application software

UltraSPECT - 00850040177008

WBR Imaging X
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177008 ()


  • SPECT system application software

GN ReSound - 05708296085989

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

  • 05708296085989 ()


  • Audiometric/hearing device software

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
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