Catalog Number

-

Brand Name

Equate

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

a0db7ac0-6894-4a30-b7ef-3e37de091b04

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

June 23, 2020

Package DI Number

20681131135607

Quantity per Package

12

Contains DI Package

00681131135603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case