Catalog Number

-

Brand Name

Rest Assured

Version/Model Number

ZWN

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)

Yes

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

5d1fc80a-f3aa-4ad9-8d54-bc7bfe1f29ca

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

10071031189528

Quantity per Package

3

Contains DI Package

00071031189521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER