UroShield Actuator 10-600-0003

GUDID 07290103420116

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.

NANOVIBRONIX INC.

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• Primary Device ID: 07290103420116
• NIH Device Record Key: f7eb6016-3bfb-4f39-a931-40136ed7674d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroShield Actuator
• Version Model Number: 3.0 actuator
• Catalog Number: 10-600-0003
• Company DUNS: 080326793
• Company Name: NANOVIBRONIX INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290103420116 [Primary]

FDA Product Code

• QMK: Extracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-30
• Device Publish Date: 2020-12-22

Devices Manufactured by NANOVIBRONIX INC.

• 07290103420277 - UroShield 3.0 Driver: 2023-08-02 The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic wa
• 07290103422011 - PainShield Patch: 2023-08-01 PainShield patch is a component of the PainShield MD system.
• 07290103421144 - PainShield 3.0 Actuator: 2023-07-24 PainShield actuator is part of the PainShield MD System.
• 07290103421328 - PainShield Plus Actuator: 2023-07-24 PainShield Plus Actuator is part of the PainShield Plus system.
• 07290103422028 - PainShield 3.0 Driver: 2023-07-24 PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area
• 07290103422035 - PainShield Plus 3.0 Driver: 2023-07-24 PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selecte
• 07290103421014 - PainShield: 2022-11-14 PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area
• 07290103421267 - PainShield MD Plus Monnthly kit: 2022-05-24 The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable