S-Rom Noiles

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

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

No FDA recalls on record, checked 24 Oct 2026.

Trade Name

S-Rom Noiles EUDAMEDGUDID

S-Rom GUDID

Generic Name

Surgical instrument/implant depth limiter, reusable

Instrument tray, reusable

Device Name

Drill Bushing

Instrument Case/Tray

Model / Ref / Catalog

63-4320, 60-1030, TruMatch Instrument Case/Tray, 634320, 601030

Primary DI / UDI-DI

10603295181842, 10603295178286

Basic UDI-DI

0603295a0022086, 0603295a000107R

Direct Marketing DI

10603295181842

10603295178286

FDA Product Code

HWT, FSM

EMDN Code

L0922, L0999

GMDN Term

Surgical instrument/implant depth limiter, reusable

Instrument tray, reusable

Device Class

Class I

Regulation Number

888.4800, 878.4800

Market of Registration

Ireland

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

EUDAMED SRN

IE-MF-000007377

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