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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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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 single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - NV/AT Disc Prep
In Commercial Distribution

  • 00857088008806 ()
610-3TX

  • 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
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a MOD Hudson-style quick-connect.
TrackX Technology, LLC
TrackX Hudson MOD T-Handle
In Commercial Distribution

  • 00857088008783 ()
1005-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a 1/4" square-style quick-connect.
TrackX Technology, LLC
TrackX 1/4" Square T-Handle
In Commercial Distribution

  • 00857088008776 ()
1004-3TX

  • 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
ASC PROCEDURE KIT 1
In Commercial Distribution

  • 00857088008769 ()
980-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a Hudson-style quick-connect.
TrackX Technology, LLC
TrackX Hudson T-Handle
In Commercial Distribution

  • 00857088008752 ()
1003-3TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 26mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS-CALIBRATOR CUP 2
In Commercial Distribution

  • 00857088008745 ()
304-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like needle.
TrackX Technology, LLC
ACUITY NEEDLE - 15 DIAMOND - 3.2 INNER
In Commercial Distribution

  • 00857088008738 ()
202-4TX

  • 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-VIOLET when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ ARRAY-VIOLET
In Commercial Distribution

  • 00857088008714 ()
703-3TX

  • Diagnostic x-ray digital imaging system workstation application software
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