Catalog Number

9400 Veil

Brand Name

Critical Cover

Version/Model Number

9400 Veil

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

a19a0bed-3d42-4ab4-9ab4-4e3efdd94017

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Package DI Number

20817583023326

Quantity per Package

6

Contains DI Package

10817583023329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case