Defend

Basic Information

• Brand Name: Defend
• Primary DI: 00843471113400
• Version / Model: FSD4-M
• Catalog Number: FSD4-M
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-24
• Public Version: 2
• Public Version Date: 2023-10-27
• Public Version Status: Update
• Public Device Record Key: 09d36e42-6fa9-4526-b7b2-0ad2baf1a28b

Device Description

DIAMOND FINISHING STRIPS DOUBLE SIDED 4MM WIDTH WITH GAP MEDIUM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZP	INSTRUMENT, DIAMOND, DENTAL	Dental	872.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63358	Dental abrasive strip, reusable	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 (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10843471113407	GS1	INNER PACK	10	In Commercial Distribution
Primary	00843471113400	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]