Duns Number:809784593
Device Description: Aquacel® Ag Advantage Surgical Advanced Antimicrobial Dressing With Silver 3.5X14" (9X35Cm Aquacel® Ag Advantage Surgical Advanced Antimicrobial Dressing With Silver 3.5X14" (9X35Cm)
Catalog Number
422607
Brand Name
AQUACEL AG+
Version/Model Number
422607
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
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
896fa205-8dfa-47e3-9181-be75c873b509
Public Version Date
October 28, 2022
Public Version Number
3
DI Record Publish Date
September 05, 2022
Package DI Number
00768455169467
Quantity per Package
10
Contains DI Package
00768455169566
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 |