Identity
- Trade Name
- Robotic, Tool Holder – Tracker FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker, single-use FDA UDI
- Model / Reference
- A40059 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311500773 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical optical-tracking spatial marker, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical optical-tracking spatial marker, single-use
Robotic, Tool Holder – Tracker by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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K231886 also covers:
- 3.5 mm Hex Head Screwdriver — ECENTIAL ROBOTICS
- 3DSRW Software — ECENTIAL ROBOTICS
- CoBot — ECENTIAL ROBOTICS
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- CoBot, Drill Guide – Cortical tip — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Sleeve — ECENTIAL ROBOTICS
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- Fixation screw — ECENTIAL ROBOTICS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ecential Robotics
Sources (1)
- FDA UDI d5229ea3-b6ff-4eeb-9d32-625e8b1a0abf 34 fields · synced May 30, 2026