Duns Number:049735438
Device Description: Silicone Adhesive Foam Dressing; Silicone Adhesive Border and Pad
Catalog Number
ZDSF33B
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZDSF33B
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
8969558d-70db-4929-b8d2-7e13263de685
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
April 11, 2019
Package DI Number
50885380122994
Quantity per Package
10
Contains DI Package
20885380122993
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |