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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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Accessory device that mounts to a 12 Inch Collar.
TrackX Technology, LLC
12 inch Distortion Plate Assembly; TX-3-3662
In Commercial Distribution

  • 00857088008424 ()


  • 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-3.5L is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ BASE-3.5L
In Commercial Distribution

  • 00857088008400 ()
603-3TX

  • 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
ATEC Lateral Kit 3.0
Not in Commercial Distribution

  • 00857088008387 ()
900-3TX

  • 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
ATEC Lateral Kit 2.0
Not in Commercial Distribution

  • 00857088008370 ()
900-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Array component that mates with an INSIGHT Base 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™ ARRAY-AQUA when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ ARRAY-AQUA
In Commercial Distribution

  • 00857088008356 ()
700-3TX

  • 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-7L is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ BASE-7L
Not in Commercial Distribution

  • 00857088008332 ()
601-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable Pointer instrument.
TrackX Technology, LLC
Pointer
In Commercial Distribution

  • 00857088008219 ()


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

  • 00857088008196 ()
300-3TX

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 9 inch C-Arm
TrackX Technology, LLC
9 inch Tracking Collar Assembly; TX-3-3300
In Commercial Distribution

  • 00857088008172 ()


  • 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. The INSIGHT™-6 SNAP is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™-6 SNAP
In Commercial Distribution

  • 00857088008134 ()
  • 00857088008141 ()
200-3TX

  • Diagnostic x-ray digital imaging system workstation application software
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