Duns Number:809784593
Device Description: Aquacel® Foam Dressing Adhesive 6 X 6 In (15X15 Cm)
Catalog Number
422350
Brand Name
AQUACEL FOAM
Version/Model Number
422350
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
4fd997a8-9397-47ba-84e5-51616674cdd0
Public Version Date
October 28, 2022
Public Version Number
2
DI Record Publish Date
September 09, 2022
Package DI Number
00768455156986
Quantity per Package
10
Contains DI Package
00768455157013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |