Duns Number:216344051
Device Description: Non-Adhesive antimicrobial hydrocellular heel dressing
Catalog Number
66800098
Brand Name
ALLEVYN AG HEEL INTERNATIONAL
Version/Model Number
66800098
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
d5331695-1834-433f-8195-e7669d3a68c8
Public Version Date
July 08, 2020
Public Version Number
3
DI Record Publish Date
May 15, 2020
Package DI Number
05000223461935
Quantity per Package
5
Contains DI Package
05000223461928
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 |