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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 - 00857088008516

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

TrackX - 00857088008509

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

TrackX - 00857088008493

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

TrackX - 00857088008448

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-6.5L is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ BASE-6.5L
In Commercial Distribution

  • 00857088008448 ()
605-3TX

  • Diagnostic x-ray digital imaging system workstation application software

TrackX - 00857088008400

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

TrackX - 00857088008394

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-2L is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ BASE-2L
In Commercial Distribution

  • 00857088008394 ()
602-3TX

  • Diagnostic x-ray digital imaging system workstation application software

TrackX - 00857088008387

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

TrackX - 00857088008370

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

TrackX - 00857088008363

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
ACCESS-LR1 SNAP
In Commercial Distribution

  • 00857088008363 ()
800-3TX

  • Diagnostic x-ray digital imaging system workstation application software

TrackX - 00857088008295

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™- A SNAP
In Commercial Distribution

  • 00857088008295 ()
402-3TX

  • Diagnostic x-ray digital imaging system workstation application software
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