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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 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 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 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
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
Not in Commercial Distribution

  • 00857088008646 ()
TX-3-4166

  • 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 150mm
In Commercial Distribution

  • 00857088008622 ()
206-4TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV RETRACT-ADAPT
Not in Commercial Distribution

  • 00857088008615 ()
TX-3-4118

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV RETRACT-ADAPT - MJF VS
Not in Commercial Distribution

  • 00857088008608 ()
TX-3-4065

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

  • 00857088008585 ()
TX-3-4064

  • 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 instruments with the 1/4" quick connect feature.
TrackX Technology, LLC
TrackX 1/4" EXT-ADAPT
In Commercial Distribution

  • 00857088008561 ()
TX-3-4026

  • Diagnostic x-ray digital imaging system workstation application software
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
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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