Duns Number:216344051
Device Description: Non Bordered Soft Silicone Hydrocellular Foam Dressing with Lock Away Layer
Catalog Number
66801748
Brand Name
ALLEVYN LIFE NON-BRDR 10.5X10.5CM
Version/Model Number
66801748
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
c66406df-9fb6-4417-b2fa-15e12ee84196
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
May 15, 2020
Package DI Number
05000223488338
Quantity per Package
10
Contains DI Package
05000223488321
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 |