Duns Number:809784593
Device Description: AQUACEL AG BURN GLOVE SZ1 (1X1PK) US
Catalog Number
403791
Brand Name
AQUACEL AG BURN
Version/Model Number
403791
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
K090254,K090254,K090254
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
8d261e97-9d73-4544-8a90-9c4bd3e96fbc
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
August 22, 2016
Package DI Number
00768455110667
Quantity per Package
1
Contains DI Package
00768455124176
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 |