Catalog Number

-

Brand Name

Moldex

Version/Model Number

1712 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

K102173,K102173,K102173

Product Code

MSH

Product Code Name

Respirator,Surgical

Public Device Record Key

46a8e8d9-cedd-4a63-9433-0f6ccffdc53d

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

50092311171208

Quantity per Package

10

Contains DI Package

00092311171203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-