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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

MediGuide™ - 05415067009807

Power Supply
ST. JUDE MEDICAL, INC.
H700980
In Commercial Distribution

  • 05415067009807 ()
H700980

  • Cardiac mapping system

MediGuide™ - 05415067009791

Power Supply
ST. JUDE MEDICAL, INC.
H700979
In Commercial Distribution

  • 05415067009791 ()
H700979

  • Cardiac mapping system
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