Identity
- Trade Name
- UroShield Actuator FDA UDI
- Generic Name
- Urinary catheter ultrasonic bacterial adhesion inhibition system actuator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 3.0 actuator FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 10-600-0003 FDA UDI
- Primary DI / UDI-DI
- 07290103420116 FDA UDI
- FDA Product Code
- QMK FDA UDI
- GMDN Term
- Urinary catheter ultrasonic bacterial adhesion inhibition system actuator FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Urinary catheter ultrasonic bacterial adhesion inhibition system actuator
UroShield Actuator by Nanovibronix Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary catheter ultrasonic bacterial adhesion inhibition system actuator.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Nanovibronix Inc.
Sources (1)
- FDA UDI f7eb6016-3bfb-4f39-a931-40136ed7674d 35 fields · synced May 30, 2026