Catalog Number

-

Brand Name

VIVIT

Version/Model Number

10111EM

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"

Yes

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

00120149-3287-4c2f-9a6a-dd8340c95a30

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 30, 2021

Package DI Number

20810084210035

Quantity per Package

10

Contains DI Package

10810084210038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case