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

  • 00850040177053 ()


  • SPECT system application software
WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177046 ()


  • SPECT system application software
WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177039 ()


  • SPECT system application software
WBR Imaging X + X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177022 ()


  • SPECT system application software
WBR Imaging X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177015 ()


  • SPECT system application software
WBR Imaging X
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177008 ()


  • SPECT system application software
TrackX adapter that enables physicians to more adequately track INSIGHT SNAPs that are placed on instruments that undergo heavier malleting forces.
TrackX Technology, LLC
TrackX Modular Malleting Adapter
In Commercial Distribution

  • 00850073646038 ()
TX-3-4369

  • Diagnostic x-ray digital imaging system workstation application software
TrackX device that consists of a non-sterile Snap component that mates with retro-reflective spheres to create a unique SNAP that enables physicians to more adequately utilize pins, such as the TrackX Hex Pins, as a Home Base.
TrackX Technology, LLC
TrackX HOME BASE VS SNAP
In Commercial Distribution

  • 00857088008943 ()
TX-3-4314

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX SE RETRACT-ADAPT 5L - MJF VS
In Commercial Distribution

  • 00857088008875 ()
TX-3-4300

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-6.5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX SE RETRACT-ADAPT 6.5L - MJF VS
Not in Commercial Distribution

  • 00857088008851 ()
TX-3-4273

  • Diagnostic x-ray digital imaging system workstation application software
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