Duns Number:809784593
Device Description: Aquacel® Hydrofiber® Burn Dressing, 23Cm X 100Cm
Catalog Number
403779
Brand Name
AQUACEL AG BURN
Version/Model Number
403779
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
3078a167-b33b-448a-b8e5-805941f2aca0
Public Version Date
October 21, 2022
Public Version Number
3
DI Record Publish Date
September 05, 2022
Package DI Number
00768455109975
Quantity per Package
3
Contains DI Package
00768455124107
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 |