Vivos MrNA

Basic Information

• Brand Name: Vivos MrNA
• Primary DI: 00810002220029
• Version / Model: 3014680794
• Company Name: JOHN'S DENTAL LABORATORY INC
• Labeler DUNS: 016649253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-08
• Public Version: 2
• Public Version Date: 2023-03-29
• Public Version Status: Update
• Public Device Record Key: e2446d77-c93f-451e-aa8f-5e663d989561
• Distribution End Date: 2023-03-28

Device Description

Anti-Snoring Vivos MrNA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRK	Device, Anti-Snoring	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38620	Custom-made mouthguard	A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. 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	00810002220029	GS1