Duns Number:049735438
Device Description: Reinforced Silver Calcium Alginate/CMC Dressing; Reinforced Pad; 4 in. x 4.75 in.
Catalog Number
ZSCA4475RF
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZSCA4475RF
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
6de49b53-642e-4a60-a4a2-5aa2d40b925c
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
April 23, 2019
Package DI Number
50885380108271
Quantity per Package
5
Contains DI Package
20885380108270
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 |