Catalog Number

-

Brand Name

SmartGuard

Version/Model Number

SGDG6

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123161,K123161,K123161,K123161

Product Code

MQC

Product Code Name

Mouthguard, Prescription

Public Device Record Key

cdd488ae-8dea-4fbf-94f7-343a80bbbbc7

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10866330000205

Quantity per Package

3

Contains DI Package

00866330000208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack