Duns Number:080935429
Device Description: AMD Antimicrobial Gauze Sponges,8 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
Catalog Number
2146AMD
Brand Name
Curity
Version/Model Number
2146AMD
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
Product Code
EFQ
Product Code Name
GAUZE/SPONGE, INTERNAL
Public Device Record Key
f1a661bb-d0dc-4078-91c1-65a2a53ec88d
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
June 29, 2018
Package DI Number
20884521154060
Quantity per Package
5000
Contains DI Package
10884521154063
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 |