Plackers-Grind No More

Basic Information

• Brand Name: Plackers-Grind No More
• Primary DI: 00651080651516
• Version / Model: 78500 82744
• Company Name: RANIR, LLC
• Labeler DUNS: 364567615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-08-26
• Public Version: 1
• Public Version Date: 2022-09-05
• Public Version Status: New
• Public Device Record Key: b9fd81d8-ee02-435f-97fe-5f658abcf72a

Device Description

Grind No More Disposable Dental Guards Up to 30 Uses 10ct. QWL46

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: 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
Primary	00651080651516	GS1
Package	10651080651513	GS1	Inner	4	In Commercial Distribution
Package	20651080651510	GS1	Case	48	In Commercial Distribution
Unit of Use	30651080651517	GS1