Skip to content

S-Rom Noiles 63-4180

by Depuy (Ireland) EUDAMEDGUDID

Active European Union

Ref 63-4180

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a0004082 Basic UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295181644 UDI-DIDate24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
S-Rom Noiles
Generic Name
Surgical screwdriver, reusable
Device Name
Screwdriver
Model / Ref / Catalog
63-4180, 634180
Primary DI / UDI-DI
10603295181644
Basic UDI-DI
0603295a0004082
Direct Marketing DI
10603295181644
FDA Product Code
HXX
EMDN Code
L26 Surgical screwdrivers, reusable
GMDN Term
Surgical screwdriver, 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

Related devices

Category: Surgical screwdriver, reusable

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No