3910947212
Ref 3910-947-212Model 08858251005899UU
3910947212 (3910-947-212) is a Class I device made by Stryker Corp., registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 08858251005899UU) and listed in FDA GUDID since 11 Feb 2022 (UDI-DI 07613327562811), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number08858251005899UU 07613327562811 | Date7 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07613327562811 | Date11 Feb 2022 | StatusListed |
Official records
- EUDAMED public site 08858251005899UU
- AccessGUDID record 07613327562811
Across registries
- EUDAMED Basic UDI-DI 08858251005899UU registered 7 Oct 2026 Active
- FDA GUDID UDI-DI 07613327562811 listed 11 Feb 2022 Listed
Timeline
- Listed FDA GUDID 07613327562811
- Registered EUDAMED 08858251005899UU
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Surgical drill guide, reusable
- Device name
- SMBU_TF10439_Drill Guide
- Model / Ref / Catalog
- 08858251005899UU, 3910-947-212, 3910947212
- Primary DI / UDI-DI
- 07613327562811
- Basic UDI-DI
- 08858251005899UU
- Direct marketing DI
- 07613327562811
- FDA product code
- FZX
- EMDN code
- L0999 Orthopaedic and traumatological surgery instruments, reusable - other
- GMDN term
- Surgical drill guide, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- EU registration type
- Standard device
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 08858251005899UU 3910-947-212 | 3910947212 |
Similar devices in this category
Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.
- Lid PIP ALX-KERI-5-002 by Keri Medical SA
- APEX Knee System WS-60005 by OMNIlife science, Inc.
- APEX Knee System XK-50019 by OMNIlife science, Inc.
- MobiliT Cup MDM064 by CORIN LTD
- POWERPRO PRO3521 by Conmed Corporation
- Arthrex® AR-S1002 by Arthrex, Inc.
- Ø12 Cannulated Curved Awl INS-1105 by OrthoXel DAC
- Tibial Nail Extraction Bolt INS-1004 by OrthoXel DAC
- Locking Pliers - Needle Nose 2421-34-000 by Tecomet,Inc
- GAUTHIER BIOMEDICAL G900100 by Gauthier Biomedical, Inc.