Catalog Number

-

Brand Name

Breathe Easy Splint

Version/Model Number

3000-0131

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070327

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

a1ae5599-f47a-4783-8166-4f94279b036e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-