Fusion® Quadcut®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Fusion® Quadcut® FDA UDI
Generic Name: Metal/carbide ENT bur, single-use FDA UDI
Device Name: BLADE 1883080EM QUADCUT 3MMX13CM M4 ROHS FDA UDI
Model / Reference: 1883080EM FDA UDI
Description: BLADE 1883080EM QUADCUT 3MMX13CM M4 ROHS FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000034009 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Metal/carbide ENT bur, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 13.0 Centimeter FDA UDI
Outer Diameter — 3.0 Millimeter FDA UDI

Category: Metal/carbide ENT bur, single-use

Fusion® Quadcut® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metal/carbide ENT bur, single-use.

JEDMED — JEDMED Instrument Company · Class I
Bur PM2-70 50K Carb Cone Ø7.0 St — Bien-Air Surgery SA · Class I
JEDMED — JEDMED Instrument Company · Class I
Bur PM2-70 80K FC Ø3.5 St — Bien-Air Surgery SA · Class I
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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI 0e9f6829-46a2-4e45-b7a6-b4bdfb3bbee9 35 fields · synced May 31, 2026