Catalog Number

-

Brand Name

Tooth Protector

Version/Model Number

10-812-13

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

BRW

Product Code Name

Protector, Dental

Public Device Record Key

6720fa57-a2d5-49df-81d9-1b3ae56859e8

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Package DI Number

30641043812130

Quantity per Package

1

Contains DI Package

10641043812136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-