Duns Number:080326793
Device Description: The UroShield disposable Actuator is a single catheter use accessory that is clipped on th The UroShield disposable Actuator is a single catheter use accessory that is clipped on the catheter's external part.After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
Catalog Number
10-600-0003
Brand Name
UroShield Actuator
Version/Model Number
3.0 actuator
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
QMK
Product Code Name
Extracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic
Public Device Record Key
f7eb6016-3bfb-4f39-a931-40136ed7674d
Public Version Date
December 30, 2020
Public Version Number
1
DI Record Publish Date
December 22, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |