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 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-ORANGE when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument. FDA UDI
- Model / Reference
- INSIGHT™ ARRAY-ORANGE FDA UDI
- Description
- 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-ORANGE when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument. FDA UDI
Identifiers
- Catalog Number
- 702-3TX FDA UDI
- Primary DI / UDI-DI
- 00857088008271 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
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
No
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
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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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 4e55c03b-e861-404c-a7ea-2fe4c57b2e7d 35 fields · synced May 30, 2026