Catalog Number

ZRHG03

Brand Name

CARDINAL HEALTH ESSENTIALS

Version/Model Number

ZRHG03

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

NAE

Product Code Name

Dressing, wound, hydrogel without drug and/or biologic

Public Device Record Key

485af17b-9607-4850-a89e-9d259150443f

Public Version Date

December 09, 2021

Public Version Number

2

DI Record Publish Date

December 10, 2018

Package DI Number

50885380114548

Quantity per Package

12

Contains DI Package

00885380114543

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE