Duns Number:809784593
Device Description: AQUACEL AG SCD DRS 9X30CM (1X10PK) NAI
Catalog Number
420670
Brand Name
AQUACEL AG
Version/Model Number
420670
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2022
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
8bbf1169-debc-4e5f-a73d-44b929e7f8fb
Public Version Date
May 23, 2022
Public Version Number
7
DI Record Publish Date
August 22, 2016
Package DI Number
00768455125111
Quantity per Package
10
Contains DI Package
00768455125104
Package Discontinue Date
May 20, 2022
Package Status
Not in Commercial Distribution
Package Type
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 |