Duns Number:961027315
Device Description: Wound and Skin Cleanser; 8 FL OZ
Catalog Number
ZRWC8
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZRWC8
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
K100613,K100613
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
fa7a4b24-9cc6-4d63-879e-997c923fb355
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
April 11, 2019
Package DI Number
50885380114517
Quantity per Package
12
Contains DI Package
00885380114512
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |