Meijer

Basic Information

• Brand Name: Meijer
• Primary DI: 00713733567404
• Version / Model: VBM736EC1
• Company Name: MEIJER, INC.
• Labeler DUNS: 006959555
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 16
• Record Status: Published
• Publish Date: 2024-04-17
• Public Version: 2
• Public Version Date: 2024-06-05
• Public Version Status: Update
• Public Device Record Key: 69285a72-e9a7-4af3-bd32-c84620f3da21

Device Description

Grind No More Ready-to-wear Dental Guard 16 Dental Guards Up To 48 Uses

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
Primary	00713733567404	GS1
Unit of Use	30713733567405	GS1
Package	10713733567401	GS1	Inner	4	In Commercial Distribution
Package	20713733567408	GS1	Shipper	48	In Commercial Distribution