Catalog Number

HCOVAL

Brand Name

CARDINAL HEALTH

Version/Model Number

HCOVAL

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

NAD

Product Code Name

Dressing, wound, occlusive

Public Device Record Key

76c08b26-aef6-4fae-ab8f-e9eb53b2fd2b

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

May 29, 2019

Package DI Number

10888499000735

Quantity per Package

20

Contains DI Package

00888499000738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE