Duns Number:809784593
Device Description: AQUACEL FOAM AG ADH 21X21(1X5) NAI
Catalog Number
420629
Brand Name
AQUACEL AG FOAM
Version/Model Number
420629
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 09, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123481
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
d642c02b-6056-4cf4-816a-040e5a578d40
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
February 09, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |