Duns Number:080935429
Device Description: AMD Antimicrobial Non-woven Sponges,4 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
Catalog Number
8047AMD
Brand Name
Curity
Version/Model Number
8047AMD
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
K011941,K011941,K011941,K011941
Product Code
EFQ
Product Code Name
GAUZE/SPONGE, INTERNAL
Public Device Record Key
4118b185-1426-48bc-acab-4ee3215abaaa
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 27, 2018
Package DI Number
30884521138159
Quantity per Package
1600
Contains DI Package
10884521138155
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 |