Catalog Number

5512934

Brand Name

LEADER

Version/Model Number

5512934

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K061375,K061375,K061375

Product Code

MSH

Product Code Name

Respirator, surgical

Public Device Record Key

77b11594-2d1e-4279-bf05-430b028ca527

Public Version Date

July 02, 2021

Public Version Number

3

DI Record Publish Date

February 10, 2020

Package DI Number

50096295137380

Quantity per Package

24

Contains DI Package

00096295137385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE