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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 - 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

SAMBA 2 Remote (iOS) - 09008737526030

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52603
In Commercial Distribution

  • 09008737526030 ()


  • Audiometric/hearing device software

AudioKey 2.0 - 09008737379353

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37935
In Commercial Distribution

  • 09008737379353 ()


  • Audiometric/hearing device software

AudioKey 1.0 - 09008737097493

Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09749
Not in Commercial Distribution

  • 09008737097493 ()


  • Audiometric/hearing device software

DreamMapper - 00606959057210

DreamMapper iOS China Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057210 ()
1136968

  • Self-care monitoring/reporting software
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