Duns Number:216344051
Device Description: ALLEVYN Ag Small Sacrum Silver Wound Dressing
Catalog Number
66020983
Brand Name
ALLEVYN Ag Small Sacrum
Version/Model Number
66020983
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
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
55ba3ff4-6ba7-41d3-9d02-64635d6d147d
Public Version Date
June 22, 2021
Public Version Number
5
DI Record Publish Date
July 04, 2019
Package DI Number
05000223459871
Quantity per Package
10
Contains DI Package
05000223459864
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 |