Plackers

Basic Information

• Brand Name: Plackers
• Primary DI: 00651080651523
• Version / Model: 78501
• Company Name: RANIR, LLC
• Labeler DUNS: 364567615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 16
• Record Status: Published
• Publish Date: 2024-04-26
• Public Version: 2
• Public Version Date: 2024-06-07
• Public Version Status: Update
• Public Device Record Key: fa653204-162f-48c4-91e2-2ed37fa8a1c4

Device Description

GRIND NO MORE 16 DENTAL GUARDS UP TO 48 USES QWL73

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
Package	10651080651520	GS1	Inner	4	In Commercial Distribution
Primary	00651080651523	GS1
Package	20651080651527	GS1	Shipper	48	In Commercial Distribution
Unit of Use	50651080651528	GS1