TrackX 500-3TX

GUDID 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

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 00857088008516
• NIH Device Record Key: 2298924f-32ea-49b8-866d-a94e9aeb9824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrackX
• Version Model Number: REVOLVE BASE-NAVIGATOR
• Catalog Number: 500-3TX
• Company DUNS: 080948525
• Company Name: TRACKX TECHNOLOGY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech
• Phone: 1-888-787-2259
• Email: support@trackx.tech

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857088008516 [Primary]

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-10
• Device Publish Date: 2023-03-02

On-Brand Devices [TrackX]

• 00860099000899: Disposable snap that snaps onto a Jamshidi for instrument tracking.
• 00860099000837: TrackX Software
• 00860099000813: Disposable snap that snaps onto a Jamshidi for instrument tracking. Instrument Tracker .125 I
• 00860099000806: Optical Tracker Snap 11 0.090 IN (previously known as Snap 1)
• 00857088008066: Disposable snap that snaps onto a Jamshidi for the purpose of instrument tracking. Component bo
• 00857088008035: Accessory device that mounts to the source side of a 12 inch C-Arm
• 00857088008028: Accessory device that mounts to the source side of a 9 inch C-Arm
• 00857088008011: Accessory device that mounts to the detector side of a 9 inch C-Arm
• 00857088008004: Accessory device that mounts to the detector side of a 12 inch C-Arm
• 00857088008233: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008226: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008202: The device consists of a sterile Calibrator that includes reflective features that facilitate im
• 00857088008196: The device consists of a sterile Screw Length Calibrator that includes reflective features that
• 00857088008134: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008103: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008097: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008318: The device consists of a sterile Calibrator that includes reflective features that facilitate im
• 00857088008295: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008370: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008363: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008424: Accessory device that mounts to a 12 Inch Collar.
• 00857088008417: Accessory device that mounts to a 9 Inch Collar
• 00857088008387: The device consists of a sterile Snap that includes reflective features that facilitate imaging
• 00857088008400: The device consists of a sterile Base component that mates with an Array component to create a u
• 00857088008394: The device consists of a sterile Base component that mates with an Array component to create a u
• 00857088008356: The device consists of a sterile Array component that mates with an INSIGHT Base component to cr
• 00857088008448: The device consists of a sterile Base component that mates with an Array component to create a u
• 00857088008431: The device consists of a sterile Base component that mates with an Array component to create a u
• 00857088008172: Accessory device that mounts to the detector side of a 9 inch C-Arm
• 00857088008165: Accessory device that mounts to the detector side of a 12 inch C-Arm
• 00857088008257: The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like
• 00857088008219: The device is a general surgical instrument: a non-sterile, reusable Pointer instrument.
• 00857088008509: The device consists of a sterile Base component that mates with an Array component to create a u
• 00857088008493: The device consists of a sterile Base component that mates with an Array component to create a u
• 00857088008516: The device consists of a sterile Base component that mates with an Array component to create a u
• 00857088008530: TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX
• 00857088008547: TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diam
• 00857088008608: TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L
• 00857088008585: TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE
• 00857088008523: TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE-B
• 00857088008486: Accessory device that mounts to the source side of a 21cm GE OEC Elite CFD.
• 00857088008479: Accessory device that mounts to the detector side of a 21cm GE OEC Elite CFD.
• 00857088008462: Accessory device that mounts to the source side of a 31cm GE OEC Elite CFD.
• 00857088008455: Accessory device that mounts to the detector side of a 31cm GE OEC Elite CFD.
• 00857088008561: TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE-B
• 00857088008677: TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX
• 00857088008554: The device is a general surgical instrument: a non-sterile, reusable Dilator instrument.
• 00857088008615: TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L
• 00857088008646: TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARR
• 00857088008653: TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARR