AccessGUDID - DEVICE: Top Quality Manufacturing (TQ26126031971)

GUDID

Device Identifier (DI) Information

Brand Name: Top Quality Manufacturing
Version or Model: 12603197
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOP QUALITY MANUFACTURING, INC.

Primary DI Number: TQ26126031971
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 113630649 *Terms of Use

Device Description: TQMPL Trimming & Finishing Carbide Bur - Composite FT - CFT 1 - 12 Blade

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:	No
Prescription Use (Rx):	No
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?
16668	Carbide dental bur, reusable	A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable 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: 68724a86-5b86-49fb-8a84-ee9d7ea6465d
Public Version Date: November 04, 2024
Public Version Number: 1
DI Record Publish Date: October 27, 2024