Handle Bone Impactor Socket Wrench Reduction Sleeve Holding Sleeve Funnel
Ref 394.701, 391.780, 498.026S, 496.724S, 391.790, 03.615.003Model USS Fracture Instruments for Insertion and Extraction, USS - Universal Spine System Locking Component, USS Fracture Bone Screw, InSight Retractor Instruments for Insertion and Extraction
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00207J8 | Date11 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- UssUSS Fracture
- Device Name
- Handle Bone Impactor Socket Wrench Reduction Sleeve Holding Sleeve FunnelClamp Collet 3D-Head Sleeve Nut Set Screw Fixation Ring Washer Low Profile Angled Polyaxial ToothedUSS Fracture Transpedicular Schanz ScrewHandle
- Model / Reference
- USS Fracture Instruments for Insertion and Extraction, 394.701, 391.780, USS - Universal Spine System Locking Component, 498.026S, USS Fracture Bone Screw, 496.724S, 391.790, InSight Retractor Instruments for Insertion and Extraction, 03.615.003
- Primary DI / UDI-DI
- 07611819112223, 07611819024700, 07611819181045, 07611819180802, 07611819024717, 07611819399853
- Basic UDI-DI
- 7611819a00207J8, 7611819a00273JM, 7611819a00289K4, 7611819a00191JJ
- Direct Marketing DI
- 07611819112223076118190247000761181902471707611819399853
- EMDN Code
- L091001, P09070302
- Device Class
- Class IClass IIb
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CH-MF-000013345
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Synthes GmbH
Properties
Other properties (9)
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No