Catalog Number

-

Brand Name

Moldex

Version/Model Number

1512 N95

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

K061859,K061859,K061859

Product Code

MSH

Product Code Name

Respirator,Surgical

Public Device Record Key

2f72258a-612e-4e28-8cc9-c498aae0bc4d

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

50092311151200

Quantity per Package

8

Contains DI Package

00092311151205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-