Catalog Number

-

Brand Name

Moldex

Version/Model Number

2212GN95-M/L

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

K062663,K062663,K062663

Product Code

MSH

Product Code Name

Respirator,Surgical

Public Device Record Key

2cb92635-66f5-431b-91b5-50dea088f6a2

Public Version Date

June 19, 2020

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

50092311221262

Quantity per Package

12

Contains DI Package

00092311221267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-