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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 Dilator instrument.
TrackX Technology, LLC
Dilator
In Commercial Distribution

  • 00857088008554 ()
204-4TX

  • 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 21-ADAPT
In Commercial Distribution

  • 00857088008547 ()
TX-3-4011

  • 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
In Commercial Distribution

  • 00857088008530 ()
TX-3-3978

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

  • 00857088008523 ()
TX-3-4066

  • 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 REVOLVE BASE-NAVIGATOR is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
REVOLVE BASE-NAVIGATOR
In Commercial Distribution

  • 00857088008516 ()
500-3TX

  • 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 FLEX-25 is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ BASE FLEX-25
In Commercial Distribution

  • 00857088008509 ()
609-3TX

  • 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 FLEX-8 is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ 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 detector side of a 21cm GE OEC Elite CFD.
TrackX Technology, LLC
21 cm Flat Panel Collar Assembly
In Commercial Distribution

  • 00857088008479 ()


  • 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
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