Catalog Number

-

Brand Name

TopCare

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

d92011f9-adea-460b-8a68-200eb1b62b55

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2020

Package DI Number

10036800410302

Quantity per Package

6

Contains DI Package

00036800410305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case