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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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HIP,ORIF PACK
MEDLINE INDUSTRIES, INC.
DYNJ80078
In Commercial Distribution

  • 40195327016266 ()
  • 10195327016265 ()
DYNJ80078

  • General surgical procedure kit, non-medicated, single-use
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 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
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
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
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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