Identity
- Trade Name
- Screwdriver Hexagonal head 3.5 mm FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Model / Reference
- A40003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311500223 FDA UDI
- 510(k) Number
- K221028 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not 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
Dry Heat Sterilization FDA UDI
Screwdriver Hexagonal head 3.5 mm by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K221028 also covers:
- 3.5 mm Hex Head Screwdriver — ECENTIAL ROBOTICS
- 3DSRW Software — ECENTIAL ROBOTICS
- CoBot — ECENTIAL ROBOTICS
- CoBot, Drill Bit — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Cortical tip — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Sleeve — ECENTIAL ROBOTICS
- CoBot, Spine Instruments tray — ECENTIAL ROBOTICS
- CoBot, Tool Holder — ECENTIAL ROBOTICS
- Fixation screw — ECENTIAL ROBOTICS
- Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm — ECENTIAL ROBOTICS
- Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm — ECENTIAL ROBOTICS
- Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mm — 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 |
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Manufacturer
- Manufacturer
- Ecential Robotics
Sources (1)
- FDA UDI cf203fae-2b07-4757-b8a1-f205b2e17a0a 35 fields · synced Jun 8, 2026