Duns Number:809784593
Device Description: AQUACEL AG BURN GLOVE SZ5 (1X1PK) US
Catalog Number
-
Brand Name
AQUACEL AG BURN
Version/Model Number
403795
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
K090254,K090254,K090254
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
d7cefcdc-5613-490d-8708-b7318a3e2b03
Public Version Date
October 18, 2022
Public Version Number
8
DI Record Publish Date
August 22, 2016
Package DI Number
00768455110780
Quantity per Package
1
Contains DI Package
00768455124268
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 |