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.

Generic Name

Orthopaedic prosthesis implantation positioning instrument, reusable

Device Name

Cutting Guide

Model / Ref / Catalog

63-3385, 633385

Primary DI / UDI-DI

10603295180104

Basic UDI-DI

0603295a002248E

Direct Marketing DI

10603295180104

FDA Product Code

HWT

EMDN Code

L0922 Orthopaedic surgery guides, reusable

GMDN Term

Orthopaedic prosthesis implantation positioning instrument, reusable

Device Class

Class I

Regulation Number

888.4800

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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