Vivos mRNA

GUDID 00810002220234

An intraoral device for the treatment of snoring and mild to moderate obstructive sleep apnea in adults. This device is reusable.

JOHN'S DENTAL LABORATORY INC

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID00810002220234
NIH Device Record Key31149776-c082-4d9c-a0f9-b41feab9e69b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivos mRNA
Version Model Number3014680794
Company DUNS016649253
Company NameJOHN'S DENTAL LABORATORY INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810002220234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-05
Device Publish Date2023-03-28