Catalog Number

7147610

Brand Name

Giggle Monster Face Masks

Version/Model Number

7147610

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

K182514,K182514,K182514

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

dc771a82-a821-42ee-915f-e058e38f147c

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

January 07, 2020

Package DI Number

00723896016138

Quantity per Package

40

Contains DI Package

00723896016121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case