Catalog Number

520

Brand Name

Vitus

Version/Model Number

520

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EZS

Product Code Name

APPLIANCE, COLOSTOMY, DISPOSABLE

Public Device Record Key

7c167efa-1ec1-471f-91e7-75eb31b42eb0

Public Version Date

May 27, 2021

Public Version Number

1

DI Record Publish Date

May 19, 2021

Package DI Number

50850025153022

Quantity per Package

400

Contains DI Package

10850025153024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case