Roadrunner

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref RR-18-480-A

by Cook Incorporated

Identity

Trade Name: Roadrunner® Wire Guide EUDAMED
Roadrunner FDA UDI
Generic Name: Gastro-urological guidewire, single-use FDA UDI
Device Name: Roadrunner Wire Guide EUDAMEDFDA UDI
Wire Guides EUDAMED
Model / Reference: RR-18-480-A EUDAMED
G22416 FDA UDI
Description: Roadrunner Wire Guide FDA UDI

Identifiers

Catalog Number: RR-18-480-A FDA UDI
Primary DI / UDI-DI: 00827002224162 EUDAMEDFDA UDI
Basic UDI-DI: B-00827002224162 EUDAMED
0827002WCM00000000009MS EUDAMED
FDA Product Code: OCY FDA UDI
EMDN Code: G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
GMDN Term: Gastro-urological guidewire, single-use FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastro-urological guidewire, single-use

Roadrunner by Cook Incorporated — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Gastro-urological guidewire, single-use.

ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
aneopiston — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Sterile Hydro-Slide Guidewire — Micro-Tech (Nanjing) Co., Ltd. · Class II
Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Valve Kit for PENTAX — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Optimos™ Guidewire — Taewoong Medical · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cook Incorporated

Sources (3)

FDA UDI 7b81b72a-a0f4-430f-b360-9b5e9062dde2 36 fields · synced Oct 7, 2026
EUDAMED f162649e-4d78-475e-b8a5-487ed65f8e84 61 fields · synced Sep 18, 2026
EUDAMED f33053fd-0d56-4f89-bf72-2abdc3413193 61 fields · synced Oct 7, 2026