TopCare

Basic Information

• Brand Name: TopCare
• Primary DI: 00036800410305
• Version / Model: SQN
• Company Name: TOPCO ASSOCIATES, LLC
• Labeler DUNS: 072943876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-06-24
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: d92011f9-adea-460b-8a68-200eb1b62b55

Device Description

Classic Mouth Guard - Rest Assured

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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	10036800410302	GS1	case	6	In Commercial Distribution
Primary	00036800410305	GS1
Unit of Use	80036800410301	GS1