Duns Number:961027315
Device Description: ADHESIVE ISLAND DRESSING 4X8IN STERILE
Catalog Number
C-DDS048S
Brand Name
CARDINAL HEALTH
Version/Model Number
C-DDS048S
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"
-
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
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
d2a7bbb9-70ec-418a-8585-5a82ea8d06ee
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
June 26, 2019
Package DI Number
50885380054073
Quantity per Package
4
Contains DI Package
20885380054072
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 |