Catalog Number

-

Brand Name

Face Mask

Version/Model Number

S-10478-S1

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

K123787,K123787,K123787

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

c496168d-c71c-4c1c-a696-bde236e8d007

Public Version Date

September 22, 2020

Public Version Number

3

DI Record Publish Date

March 09, 2020

Package DI Number

30851253007916

Quantity per Package

6

Contains DI Package

10851253007912

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-