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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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The device consists of a sterile Base component that mates with an Array component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT BASE FLEX-8 is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHTâ„¢ BASE FLEX-8
In Commercial Distribution

  • 00857088008493 ()
608-3TX

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the source side of a 21cm GE OEC Elite CFD.
TrackX Technology, LLC
21 cm Flat Panel Cap Assembly
In Commercial Distribution

  • 00857088008486 ()


  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the source side of a 31cm GE OEC Elite CFD.
TrackX Technology, LLC
31 cm Flat Panel Cap Assembly
In Commercial Distribution

  • 00857088008462 ()


  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 31cm GE OEC Elite CFD.
TrackX Technology, LLC
31 cm Flat Panel Collar Assembly
In Commercial Distribution

  • 00857088008455 ()


  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Base component that mates with an Array component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT BASE-6.5L is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHTâ„¢ BASE-6.5L
In Commercial Distribution

  • 00857088008448 ()
605-3TX

  • 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
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-NV/AT DISC PREP SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX AT INSERT-ADAPT - MJF VS
In Commercial Distribution

  • 00857088008820 ()
TX-3-4229

  • 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 NV RETRACT-ADAPT - MJF VS
In Commercial Distribution

  • 00857088008813 ()
TX-3-4201

  • Diagnostic x-ray digital imaging system workstation application software
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