Catalog Number

695

Brand Name

Critical Cover

Version/Model Number

695

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

K092824,K092824,K092824

Product Code

MSH

Product Code Name

Respirator,Surgical

Public Device Record Key

4ae0c77a-ce9c-4b77-865e-aafa1e6487ff

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

November 03, 2016

Package DI Number

20817583020127

Quantity per Package

6

Contains DI Package

10817583020120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE