Duns Number:809784593
Device Description: Aquacel® Ag Advantage Enhanced Hydrofiber® Dressing With Silver .39X18" (1X45Cm)
Catalog Number
422301
Brand Name
AQUACEL AG+ ADVANTAGE
Version/Model Number
422301
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K121275,K121275,K121275
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
8ea1707a-9290-48cb-97d9-fd533c41d5f7
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
September 05, 2022
Package DI Number
00768455145676
Quantity per Package
5
Contains DI Package
00768455154401
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 |