NovaBright

Basic Information

• Brand Name: NovaBright
• Primary DI: 00816537021322
• Version / Model: 14203-002
• Company Name: NANOVA BIO MATERIALS INC
• Labeler DUNS: 006084093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-05-22
• Public Version: 1
• Public Version Date: 2020-06-01
• Public Version Status: New
• Public Device Record Key: 804ecec7-2516-4b5b-95d9-da9f9b461c6c

Device Description

0.4mL Sodium Fluoride White Varnish (Caramel) - 2 Units

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBH	VARNISH, CAVITY	Dental	872.3260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42341	Fluoride gel	A preparation in the form of a gel, containing fluorine, in a chemical form and sufficient concentration to permit the treatment of tooth tissues by topical application. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816537020974	GS1
Primary	00816537021322	GS1

Customer Contacts

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