AccessGUDID - DEVICE: DragonFly™ BUR, CTR, CYL, 80MM L, 1.8MM Ø, BurShield (00844505010276)

GUDID

Device Identifier (DI) Information

Brand Name: DragonFly™ BUR, CTR, CYL, 80MM L, 1.8MM Ø, BurShield
Version or Model: 954-80-018-SL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Grace Medical, Inc.

Primary DI Number: 00844505010276
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030849173 *Terms of Use

Device Description: DragonFly™ CYLINDER CUTTING BUR 80MM LENGTH, 1.8MM Ø WITH BurShield™ - USED WITH 950-002 HANDPIECE

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EQJ	Bur, Ear, Nose And Throat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90799224-501f-4baa-9105-689415525941
Public Version Date: October 23, 2018
Public Version Number: 1
DI Record Publish Date: September 22, 2018