AccessGUDID - DEVICE: DragonFly™ BUR, DMD, RD, 95MM L, 1.0MM Ø, BurShield (00844505009614)

GUDID

Device Identifier (DI) Information

Brand Name: DragonFly™ BUR, DMD, RD, 95MM L, 1.0MM Ø, BurShield
Version or Model: 951-95-010-SL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Grace Medical, Inc.

Primary DI Number: 00844505009614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030849173 *Terms of Use

Device Description: DragonFly™ ROUND DIAMOND BUR 95MM LENGTH, 1.0MM 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?
45527	Diamond ENT bur, single-use	A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. 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: 97214baf-bb1e-43d3-8550-07fc0efb93a7
Public Version Date: October 23, 2018
Public Version Number: 1
DI Record Publish Date: September 22, 2018