Catalog Number

-

Brand Name

Vivos MrNA

Version/Model Number

3014680794

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K030440,K060388,K130067,K130797,K962516,K973884

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

e2446d77-c93f-451e-aa8f-5e663d989561

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-