Duns Number:961027315
Device Description: OIL EMULSION DRESSING, 3INX3IN,STER
Catalog Number
C-WNM33
Brand Name
CARDINAL HEALTH
Version/Model Number
C-WNM33
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2024
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"
-
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
K921290,K921290,K921290
Product Code
GER
Product Code Name
GAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL)
Public Device Record Key
4ad31a54-d62e-407d-a913-61486a63fc4f
Public Version Date
November 13, 2020
Public Version Number
2
DI Record Publish Date
May 29, 2019
Package DI Number
20885380052276
Quantity per Package
50
Contains DI Package
10885380052279
Package Discontinue Date
December 31, 2024
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |