← Back to catalogue

TrackX

FDA UDI

Class II (US FDA UDI)

by TRACKX TECHNOLOGY Inc.

Identity

Trade Name
TrackX FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
ATEC Lateral Kit 2.0 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
900-3TX FDA UDI
Primary DI / UDI-DI
00857088008370 FDA UDI
FDA Product Code
OWB FDA UDI
LLZ FDA UDI
JAA FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
892.2050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

TrackX by TRACKX TECHNOLOGY Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
TRACKX TECHNOLOGY Inc.

Sources (1)

  • FDA UDI 3cd3e255-0169-4e2c-a3af-f1ebed97a8e8 36 fields · synced May 30, 2026