Vivos MrNA

GUDID 00810002220029

Anti-Snoring Vivos MrNA

JOHN'S DENTAL LABORATORY INC

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Primary Device ID	00810002220029
NIH Device Record Key	e2446d77-c93f-451e-aa8f-5e663d989561
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vivos MrNA
Version Model Number	3014680794
Company DUNS	016649253
Company Name	JOHN'S DENTAL LABORATORY INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810002220029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K030440

FDA Product Code

LRK	Device, Anti-Snoring

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-09-16
Device Publish Date	2020-09-08