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Radifocus

FDA UDI

Class II (US FDA UDI)

by Terumo Corp.

Identity

Trade Name
RADIFOCUS FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
RADIFOCUS Obturator FDA UDI
Model / Reference
XX902 FDA UDI
Description
RADIFOCUS Obturator FDA UDI

Identifiers

Catalog Number
XX*RF050925A FDA UDI
Primary DI / UDI-DI
04987350774613 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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
Outer Diameter — 3.0 Millimeter FDA UDI
Length — 25 Centimeter FDA UDI

Category: Vascular catheter introduction set, nonimplantable

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

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Terumo Corp.

Sources (1)

  • FDA UDI 51ba9d3b-ed07-4063-a67c-3b11428d9c05 37 fields · synced May 30, 2026