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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 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™-6 SNAP Kit is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
NSIGHT™-6 SNAP Kit
Not in Commercial Distribution

  • 00857088008233 ()
200-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
VISION™- I+ SNAP
In Commercial Distribution

  • 00857088008226 ()
400-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Calibrator that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
Calibrator
Not in Commercial Distribution

  • 00857088008202 ()
301-3TX

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 12 inch C-Arm
TrackX Technology, LLC
12 inch Tracking Collar Assembly; TX-3-3307
In Commercial Distribution

  • 00857088008165 ()


  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
VISION™-V SNAP
In Commercial Distribution

  • 00857088008097 ()
  • 00857088008080 ()
TX-3-3109

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the source side of a 9 inch C-Arm
TrackX Technology, LLC
9 inch Source Cap Original Assembly
In Commercial Distribution

  • 00857088008028 ()
TX-3-3091

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 12 inch C-Arm
TrackX Technology, LLC
12 inch C-Arm Collar Assembly
Not in Commercial Distribution

  • 00857088008004 ()
TX-3-3142

  • 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-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
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 21mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS-CALIBRATOR CUP 1
In Commercial Distribution

  • 00857088008790 ()
303-3TX

  • Diagnostic x-ray digital imaging system workstation application software
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