Catalog Number

-

Brand Name

Plackers-Grind No More

Version/Model Number

78500 82744

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"

Yes

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

b9fd81d8-ee02-435f-97fe-5f658abcf72a

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

Package DI Number

10651080651513

Quantity per Package

4

Contains DI Package

00651080651516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner