Single Use Instruments SYNFIX Evolution Protection Sleeve for Screwdriver Awl

by Synthes GmbH

Ref 03.835.012SModel Single Use Instruments Spine Protection Sleeve

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number7611819a00773KE Basic UDI-DI 07612334105219UDI-DI	Date11 Jul 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Single Use Instruments SYNFIX Evolution Protection Sleeve for Screwdriver Awl
Model / Reference: Single Use Instruments Spine Protection Sleeve, 03.835.012S

Primary DI / UDI-DI: 07612334105219
Basic UDI-DI: 7611819a00773KE
Unit of Use DI: 87612334105215
EMDN Code: Z12139099 Various orthopaedic and traumatology instruments - other

Device Class: Class IIa
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

Volt

Class IIb
Cannulated Screw Stainless Steel

Class IIb
Lc-Dcp

Class I
Va Lcp

Class IIb
Locking Screw

Class IIb
Volt

Class IIb

See all devices from Synthes GmbH →

Properties

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No