Defend

Basic Information

• Brand Name: Defend
• Primary DI: 00843471127131
• Version / Model: BB-1440
• Catalog Number: BB-1440
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-30
• Public Version: 1
• Public Version Date: 2022-11-07
• Public Version Status: New
• Public Device Record Key: 102fb61d-78ec-4665-bbca-f200f849159c

Device Description

Bendable Applicator Brush - Blue

Device Characteristics

• Single Use: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXR	APPLICATOR, RESIN	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30843471127132	GS1	Case	32	In Commercial Distribution
Package	20843471127135	GS1	Box	4	In Commercial Distribution
Primary	00843471127131	GS1
Package	10843471127138	GS1	Tube	100	In Commercial Distribution

Customer Contacts

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