AccessGUDID - DEVICE: TrackX (00857088008660)

GUDID

Device Identifier (DI) Information

Brand Name: TrackX
Version or Model: TrackX NV INSERT-ADAPT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TX-3-4089
Company Name: TrackX Technology, LLC

Primary DI Number: 00857088008660
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080948525 *Terms of Use

Device Description: TrackX reusable adapter that enables physicians to more adequately utilize the Insight Base - NV/AT Disc Prep SNAP on their surgical instrument.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58473	Diagnostic x-ray digital imaging system workstation application software	An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWB	Interventional Fluoroscopic X-Ray System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173736	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c7d4295-70dc-4e43-b290-566a1c39592e
Public Version Date: January 22, 2025
Public Version Number: 2
DI Record Publish Date: September 12, 2024