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 22 Oct 2026.

Generic Name

Orthopaedic prosthesis implantation positioning instrument, reusable

Device Name

Knee Instruments Impaction Cap

Model / Ref / Catalog

63-3805A, 633805A

Primary DI / UDI-DI

10603295180692

Basic UDI-DI

0603295a002238C

Direct Marketing DI

10603295180692

FDA Product Code

HWA

EMDN Code

L091199 Orthopaedic prosthetics instruments, reusable - other

GMDN Term

Orthopaedic prosthesis implantation positioning instrument, reusable

Device Class

Class I

Regulation Number

888.4540

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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