Catalog Number

-

Brand Name

Uline Surgical Mask 50/BX

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

K182514,K182514,K182514

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

ec463dd3-290e-4cd2-b5a8-f3d72744b567

Public Version Date

August 25, 2020

Public Version Number

1

DI Record Publish Date

August 17, 2020

Package DI Number

30850015055011

Quantity per Package

6

Contains DI Package

10850015055017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-