Identity
- Trade Name
- TrackX FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
- Device Name
- TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 21mm with the Calibrator 2.0. FDA UDI
- Model / Reference
- ACCESS 21-ADAPT FDA UDI
- Description
- TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 21mm with the Calibrator 2.0. FDA UDI
Identifiers
- Catalog Number
- TX-3-4011 FDA UDI
- Primary DI / UDI-DI
- 00857088008547 FDA UDI
- 510(k) Number
- K173736 FDA UDI
- FDA Product Code
- OWB 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
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic x-ray digital imaging system workstation application software
TrackX by TRACKX TECHNOLOGY Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173736 also covers:
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- TRACKX TECHNOLOGY Inc.
Sources (1)
- FDA UDI bd445911-8e50-4e81-828a-9c78f4c5dd18 36 fields · synced May 30, 2026