Catalog Number

RES-01-3121

Brand Name

E-Guard Blue

Version/Model Number

RES-01-3121

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201173

Product Code

MQC

Product Code Name

Mouthguard, Prescription

Public Device Record Key

fc74e2eb-c916-4f19-b4b8-1a4687c28e67

Public Version Date

December 25, 2020

Public Version Number

1

DI Record Publish Date

December 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-