Identity
- Trade Name
- UroShield 3.0 Driver FDA UDI
- Generic Name
- Urinary catheter ultrasonic bacterial adhesion inhibition system FDA UDI
- Device Name
- The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic waves on Urinary catheter to prevent bacterial adhesion and minimized risk of CAUTI (Catheter Associated Urinary Tract Infections). FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic waves on Urinary catheter to prevent bacterial adhesion and minimized risk of CAUTI (Catheter Associated Urinary Tract Infections). FDA UDI
Identifiers
- Catalog Number
- 10-800-0003 FDA UDI
- Primary DI / UDI-DI
- 07290103420277 FDA UDI
- FDA Product Code
- QMK FDA UDI
- GMDN Term
- Urinary catheter ultrasonic bacterial adhesion inhibition system FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Urinary catheter ultrasonic bacterial adhesion inhibition system
UroShield 3.0 Driver 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.
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 c187b437-af95-4b54-a6cc-5975a19dcb3f 36 fields · synced Jun 8, 2026