Guide Wire M

FDA UDI

Class II (US FDA UDI)

by Terumo Corp.

Identity

Trade Name: GUIDE WIRE M FDA UDI
Generic Name: General-purpose non-vascular guidewire FDA UDI
Device Name: RADIFOCUS GUIDE WIRE M Small Vessel Gold FDA UDI
Model / Reference: GM1814 FDA UDI
Description: RADIFOCUS GUIDE WIRE M Small Vessel Gold FDA UDI

Identifiers

Catalog Number: RF*RB18185TA FDA UDI
Primary DI / UDI-DI: 04987350774255 FDA UDI
FDA Product Code: GCJ FDA UDI
DQX FDA UDI
GMDN Term: General-purpose non-vascular guidewire FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
870.1330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 0.46 Millimeter FDA UDI
Length — 180 Centimeter FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use General-purpose non-vascular guidewire

Guide Wire M by Terumo Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as General-purpose non-vascular guidewire.

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POINTER™ Nitinol Guidewire — Argon Medical Devices, Inc. · Class II
PTFE Coated Urological Guidewire — Lake Region Medical · Class I
RX Cholangiogram Kit — Boston Scientific · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Terumo Corp.

Sources (1)

FDA UDI e21f11c2-cc81-4e06-983f-145cd569098e 37 fields · synced Jun 1, 2026