AccessGUDID - DEVICE: A.S.A.P.® Diamond Polishing Brushes 6-Pack (07540172017145)

GUDID

Device Identifier (DI) Information

Brand Name: A.S.A.P.® Diamond Polishing Brushes 6-Pack
Version or Model: 133158
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 133158
Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Primary DI Number: 07540172017145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626406016 *Terms of Use

Device Description: Dental abrasive disk

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?
35807	Dental abrasive disk, reusable	A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHJ	DISK, ABRASIVE

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
Storage Environment Temperature: less than 25 Degrees Celsius
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6 x 11mm polishers
Outer Diameter: 11 Millimeter

Device Record Status

Public Device Record Key: 58eeaabf-7460-40d3-8c33-4fc256bedc21
Public Version Date: February 01, 2021
Public Version Number: 1
DI Record Publish Date: January 22, 2021