Catalog Number

-

Brand Name

Rest Assured

Version/Model Number

1C4

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

a19497b6-b1e8-4418-b447-74258bdcb0f0

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Package DI Number

20651080000004

Quantity per Package

4

Contains DI Package

10651080000007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case