Rad®

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: RAD® FDA UDI
Generic Name: Metal/carbide ENT bur, single-use FDA UDI
Device Name: BUR 1883670HS RAD55 3PK HI SPD CVD 3.6MM FDA UDI
Model / Reference: 1883670HS FDA UDI
Description: BUR 1883670HS RAD55 3PK HI SPD CVD 3.6MM FDA UDI

Identifiers

Primary DI / UDI-DI: 20681490692810 FDA UDI
FDA Product Code: EQJ FDA UDI
GMDN Term: Metal/carbide ENT bur, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4140 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Metal/carbide ENT bur, single-use

Rad® by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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JEDMED — JEDMED Instrument Company · Class I
OSSEOUS Burs-stainless Steel — EON MEDITECH PRIVATE LIMITED · Class I
GYRUS ACMI — Gyrus Acmi, Inc. · Class I
Bur PM2-95 80K Steel Ø1.8 St — Bien-Air Surgery SA · 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 I	Pending data

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI 1043048b-6b39-4be7-be99-d082f95e8be0 34 fields · synced May 31, 2026