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Glidewire

FDA UDI

Class II (US FDA UDI)

by Terumo Corp.

Identity

Trade Name
GLIDEWIRE FDA UDI
Generic Name
General-purpose non-vascular guidewire FDA UDI
Device Name
RADIFOCUS GLIDEWIRE FDA UDI
Model / Reference
GR3808 FDA UDI
Description
RADIFOCUS GLIDEWIRE FDA UDI

Identifiers

Catalog Number
RF*GA38183A FDA UDI
Primary DI / UDI-DI
04987350773395 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 180 Centimeter FDA UDI
Outer Diameter — 0.97 Millimeter FDA UDI

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

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

Similar devices

Also classified as General-purpose non-vascular guidewire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Terumo Corp.

Sources (1)

  • FDA UDI 6291d617-cc4a-47a1-811e-7fc3a680499a 37 fields · synced Jun 8, 2026