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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 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 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 is a general surgical instrument: a non-sterile, reusable Pin instrument.
TrackX Technology, LLC
Hex Pin 6mm x 100mm
In Commercial Distribution

  • 00857088008707 ()
205-4TX

  • 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 - DS Disc Prep - MJF VS
In Commercial Distribution

  • 00857088008691 ()
TX-3-4182

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX-25 SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX PE ADAPT - MJF VS
In Commercial Distribution

  • 00857088008677 ()
TX-3-4121

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to more adequately utilize the Insight Base - NV/AT Disc Prep SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV INSERT-ADAPT
In Commercial Distribution

  • 00857088008660 ()
TX-3-4089

  • 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 - MJF VS
In Commercial Distribution

  • 00857088008653 ()
TX-3-4079

  • Diagnostic x-ray digital imaging system workstation application software
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