Catalog Number

522

Brand Name

Vitus

Version/Model Number

522

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

6496c74b-7cad-400c-afb8-9cd70cbb2a6b

Public Version Date

May 27, 2021

Public Version Number

1

DI Record Publish Date

May 19, 2021

Package DI Number

10850025153048

Quantity per Package

10

Contains DI Package

00850025153041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box