AccessGUDID - DEVICE: Darby Dental Supply, LLC (00889813059739)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: 5255234
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5255234
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 00889813059739
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: STEEL BUR RA 7

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?
64949	Steel dental bur, single-use	A rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJL	BUR, DENTAL

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: No
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: 161bcaca-324f-4818-980a-fdf12a1083af
Public Version Date: April 10, 2023
Public Version Number: 1
DI Record Publish Date: April 01, 2023