Duns Number:216344051
Device Description: Silicone gel adhesive hydrocellular foam dressing
Catalog Number
66802141, 66802131
Brand Name
ALLEVYN GENTLE 15CM X 15CM CTN 3
Version/Model Number
66802141
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
557615f0-02ca-4147-812e-0eb5f511bcb2
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
May 15, 2020
Package DI Number
05000223495206
Quantity per Package
3
Contains DI Package
05000223494797
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton 66802141
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 |