Catalog Number

-

Brand Name

Sure & Me

Version/Model Number

MP002-5

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

K202577,K202577,K202577

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

53835d37-5a72-49ef-97d8-58327ca73803

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Package DI Number

26973069130002

Quantity per Package

40

Contains DI Package

16973069130005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-