Duns Number:216344051
Device Description: Non-Adhesive antimicrobial hydrocellular dressing
Catalog Number
66020978
Brand Name
ALLEVYN AG NON ADHESIVE 4X4" CTN10
Version/Model Number
66020978
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
K063835,K063835,K063835
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
0d7de837-fcd7-41fa-bd38-ae2dda64d1f8
Public Version Date
July 08, 2020
Public Version Number
3
DI Record Publish Date
May 15, 2020
Package DI Number
05000223459963
Quantity per Package
10
Contains DI Package
05000223459956
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 | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |