Duns Number:080935429
Device Description: AMD Antimicrobial Super Sponges,Medium, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
Catalog Number
1167AMD
Brand Name
Kerlix
Version/Model Number
1167AMD
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)
Yes
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
98967c70-02ec-44f3-9a88-86f40ebcdc60
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
June 29, 2018
Package DI Number
20884521154046
Quantity per Package
600
Contains DI Package
10884521154049
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 |