Duns Number:216344051
Device Description: ALLEVYN Adhesive 3in x 3in Adhesive hydrocellular polyurethane dressing
Catalog Number
66020400, 66020043, 66000043
Brand Name
ALLEVYN Adhesive 3in x 3in
Version/Model Number
66020400
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
76c1f3ba-1818-451a-8bde-5ca94e1d6860
Public Version Date
June 22, 2021
Public Version Number
6
DI Record Publish Date
July 04, 2019
Package DI Number
05000223482824
Quantity per Package
10
Contains DI Package
05000223415570
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 |