Walgreens

Basic Information

• Brand Name: Walgreens
• Primary DI: 00311917046877
• Version / Model: 630109
• Catalog Number: SQN5494SB1
• Company Name: WALGREEN CO.
• Labeler DUNS: 008965063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-01-18
• Public Version: 1
• Public Version Date: 2024-01-26
• Public Version Status: New
• Public Device Record Key: c7e700ac-44d3-48dc-9e1b-c1c47c774232

Device Description

Walgreens Dental Guard For Nighttime Teeth Grinding (Bruxism) 2 Dental Guards, 1 Storage Case, 1 Fitting Tray

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
OBR	Mouthguard, Over-The-Counter	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
38621	Mouthguard, reusable	A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10311917046874	GS1	Shipper	6	In Commercial Distribution
Primary	00311917046877	GS1
Unit of Use	40311917046875	GS1

Customer Contacts

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