Glidewire

FDA UDI

Class II (US FDA UDI)

by Terumo Corp.

Identity

Trade Name: GLIDEWIRE FDA UDI
Generic Name: Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name: RADIFOCUS GLIDEWIRE FDA UDI
Model / Reference: EWSS4520 FDA UDI
Description: RADIFOCUS GLIDEWIRE FDA UDI

Identifiers

Catalog Number: RF*PA18453E FDA UDI
Primary DI / UDI-DI: 04987350756152 FDA UDI
FDA Product Code: OCY FDA UDI
DQX FDA UDI
GCJ FDA UDI
GMDN Term: Cardiac/peripheral vascular guidewire, single-use 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: Length — 450 Centimeter FDA UDI
Outer Diameter — 0.51 Millimeter FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use Gastro-urological guidewire, single-use

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

Similar devices

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

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Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Optimos™ Guidewire — Taewoong Medical · 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 76deed37-af51-4822-9ea0-02a85df414b7 37 fields · synced Jun 7, 2026