Catalog Number

-

Brand Name

ClearDream

Version/Model Number

ClearDream

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

-

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

-

FDA Premarket Submission

K133390

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

5bc5c602-7358-4e64-b7da-38f7b34d1421

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-