Duns Number:809784593
Device Description: Aquacel Ag Surgical Sp Hydrofiber Surgical Cover Dressing 3.5" X 4"
Catalog Number
413557
Brand Name
AQUACEL AG SURGICAL
Version/Model Number
413557
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)
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
3c5d449d-a43d-4e25-87c6-253f685ebb0d
Public Version Date
October 12, 2022
Public Version Number
5
DI Record Publish Date
August 22, 2016
Package DI Number
10768455130600
Quantity per Package
2
Contains DI Package
00768455130603
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| 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 |