Duns Number:809784593
Device Description: AQUACEL FOAM AG ADH 10X10CM(10PK) NAI
Catalog Number
-
Brand Name
AQUACEL AG FOAM
Version/Model Number
420681
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
K123481,K123481,K123481
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
28c487c7-c7dc-4f56-8317-87e6912ab7d4
Public Version Date
October 18, 2022
Public Version Number
7
DI Record Publish Date
August 22, 2016
Package DI Number
00768455127160
Quantity per Package
10
Contains DI Package
00768455127153
Package Discontinue Date
-
Package Status
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 |