Catalog Number

-

Brand Name

Kroger

Version/Model Number

SQN

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

-

Product Code

OBR

Product Code Name

Mouthguard, Over-The-Counter

Public Device Record Key

4d307d6d-6a82-4e03-a507-a2894dac855e

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

May 15, 2020

Package DI Number

10041260371469

Quantity per Package

6

Contains DI Package

00041260371462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case