Duns Number:080935429
Device Description: AMD Antimicrobial Fenestrated Foam Disc Dressing,0.5% Polyhexamethylene Biguanide HCI (PHM AMD Antimicrobial Fenestrated Foam Disc Dressing,0.5% Polyhexamethylene Biguanide HCI (PHMB)
Catalog Number
55512AMD
Brand Name
Kendall
Version/Model Number
55512AMD
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)
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
8ca0b9d9-a8d4-4d3b-8046-80b2a15305ce
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
June 30, 2018
Package DI Number
00884521065522
Quantity per Package
40
Contains DI Package
10884521065512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |