Scoop Dilator Stylet Strong Arm

by Synthes GmbH 8 variants

Ref 03.816.816Model INSIGHT Lateral Access Osteosynthesis Reusable Instruments

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	Number7611819a00088JQ Basic UDI-DI 07611819583924UDI-DI	Date14 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Withdrawn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: Scoop Dilator Stylet Strong Arm
Model / Reference: INSIGHT Lateral Access Osteosynthesis Reusable Instruments, 03.816.816

Primary DI / UDI-DI: 07611819583924
Basic UDI-DI: 7611819a00088JQ
Direct Marketing DI: 07611819583924
EMDN Code: L091099 Osteosynthesis instruments, reusable - other

Device Class: Class I
EU market of registration: Belgium

Manufacturer details

EUDAMED SRN: CH-MF-000013345
Authorised representative: DePuy Ireland UC IE-AR-000009328

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Va Lcp

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Volt

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Properties

Reusable

Other properties (12)

Sterile: No
Implantable: 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