EUDAMED device

Double Flexible Tip Wire Guide With Hydrophilic Coating

EUDAMED device 00827002187924 · Cook Incorporated

Key facts

Primary DI 00827002187924
Trade name Double Flexible Tip Wire Guide With Hydrophilic Coating
Device name Urology Wire Guides, [Roadrunner® Hydrophilic PC Wire Guide With Flexible Shaft and Short Taper; Roadrunner® PC Double Flexible Tip Wire Guide With Hydrophilic Coating]
Reference or catalog number RSPC-035145-DF-I-AQ
Manufacturer Cook Incorporated
Manufacturer SRN US-MF-000003180
Risk class Class IIa
EMDN code U0601
EMDN description UROLOGICAL GUIDEWIRES, HYDROPHILIC
Legislation mdr
Implantable No
Sterile Yes
Single use Yes
Status date Nov 17, 2025

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

Browse all EUDAMED devices