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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 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
Accessory device that mounts to the detector side of a 31cm GE OEC Elite CFD.
TrackX Technology, LLC
31 cm Flat Panel Collar Assembly
In Commercial Distribution

  • 00857088008455 ()


  • 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-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
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-5L is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ BASE-5L
In Commercial Distribution

  • 00857088008431 ()
604-3TX

  • Diagnostic x-ray digital imaging system workstation application software
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
Accessory device that mounts to a 9 Inch Collar
TrackX Technology, LLC
9 Inch Distortion Plate Assembly; TX-3-3675
In Commercial Distribution

  • 00857088008417 ()


  • 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 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
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