Catalog Number

-

Brand Name

Meijer

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

eed17421-f8e6-4ee2-89c8-4bfbe16b2ef4

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

10651080000014

Quantity per Package

3

Contains DI Package

00651080000017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner