DragonFly™ BUR, CTR, RD, 80MM L, 0.7MM Ø, BurShield

Basic Information

• Brand Name: DragonFly™ BUR, CTR, RD, 80MM L, 0.7MM Ø, BurShield
• Primary DI: 00844505010092
• Version / Model: 952-80-007-SL
• Company Name: Grace Medical, Inc.
• Labeler DUNS: 030849173
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-22
• Public Version: 1
• Public Version Date: 2018-10-23
• Public Version Status: New
• Public Device Record Key: 2f3bc6c6-7cbf-43e5-ab66-9e4b501c7bbc

Device Description

DragonFly™ ROUND CUTTING BUR 80MM LENGTH, 0.7MM Ø WITH BurShield™ - USED WITH 950-002 HANDPIECE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	874.4140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34848	Metal/carbide ENT bur, single-use	A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844505010092	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]