Duns Number:961027315
Device Description: Composite Dressing4 IN X 12 IN.Superficial and non-infected wounds: -Post-operative wounds Composite Dressing4 IN X 12 IN.Superficial and non-infected wounds: -Post-operative wounds-Skin grafts and donor sites-Lacerations and abrasions-Minor burns and scalds
Catalog Number
COMP412
Brand Name
CARDINAL HEALTH
Version/Model Number
COMP412
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
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
a4b5d155-b9d0-4368-bc01-20f39bcbd0a7
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
December 03, 2018
Package DI Number
10888499000902
Quantity per Package
20
Contains DI Package
00888499000905
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 |