Vivos MrNA

GUDID 00810002220029

Anti-Snoring Vivos MrNA

JOHN'S DENTAL LABORATORY INC

Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard
Primary Device ID00810002220029
NIH Device Record Keye2446d77-c93f-451e-aa8f-5e663d989561
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 Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]
GS100810002220029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
LRKDevice, Anti-Snoring
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 Date2020-09-16
Device Publish Date2020-09-08