Microdont

Basic Information

• Brand Name: Microdont
• Primary DI: 07898229800548
• Version / Model: 10.302.001
• Catalog Number: 10.302.001
• Company Name: 3R - INDUSTRIA E COMERCIO EIRELI
• Labeler DUNS: 907197222
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-01-17
• Public Version: 1
• Public Version Date: 2022-01-25
• Public Version Status: New
• Public Device Record Key: 2dafdd7c-a620-4dd5-b65c-b91221905164

Device Description

Abrasive Polyester Strip - 2,5mm - Box w/100 pcs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHM	Strip, Polishing Agent	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35702	Dental abrasive strip, single-use	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07908516834085	GS1
Primary	07898229800548	GS1