Catalog Number

-

Brand Name

Le Petit Masque

Version/Model Number

GCAPTPK

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

K133070,K133070,K133070

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

aaef4067-c994-43e4-a002-da6e9529b196

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

Package DI Number

50732224000386

Quantity per Package

10

Contains DI Package

10732224000388

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-