Catalog Number

-

Brand Name

The Doctor's

Version/Model Number

79922B

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)

Yes

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

004e89f2-be4a-4572-8d77-1c30fdcc60a6

Public Version Date

July 22, 2020

Public Version Number

1

DI Record Publish Date

July 14, 2020

Package DI Number

10042037101432

Quantity per Package

1

Contains DI Package

00042037799229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single