Catalog Number

501

Brand Name

Vitus

Version/Model Number

501

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

-

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

048a3fc2-2c95-4305-a2b2-3fcc3baaa299

Public Version Date

November 24, 2021

Public Version Number

2

DI Record Publish Date

May 19, 2021

Package DI Number

10850025153109

Quantity per Package

1

Contains DI Package

00850025153102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box