DragonFly™ BUR, CTR, RD, 80MM L, 0.5MM Ø, BurShield

FDA UDI

Class I (US FDA UDI)

by Grace Medical, Inc.

Identity

Trade Name: DragonFly™ BUR, CTR, RD, 80MM L, 0.5MM Ø, BurShield FDA UDI
Generic Name: Metal/carbide ENT bur, single-use FDA UDI
Device Name: DragonFly™ ROUND CUTTING BUR 80MM LENGTH, 0.5MM Ø WITH BurShield™ - USED WITH 950-002 HANDPIECE FDA UDI
Model / Reference: 952-80-005-SL FDA UDI
Description: DragonFly™ ROUND CUTTING BUR 80MM LENGTH, 0.5MM Ø WITH BurShield™ - USED WITH 950-002 HANDPIECE FDA UDI

Identifiers

Primary DI / UDI-DI: 00844505010061 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Metal/carbide ENT bur, single-use

DragonFly™ BUR, CTR, RD, 80MM L, 0.5MM Ø, BurShield by Grace Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Grace Medical, Inc.

Sources (1)

FDA UDI 70edccf2-8293-4f21-bb99-1b5f502e8c5b 34 fields · synced Jun 6, 2026