Wirion System kit Finished Good P2-9-0705-S

GUDID 07290015512015

The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire. SYSTEM COMPONENTS: 1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039

GARDIA MEDICAL LTD

Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire Embolic protection filtering guidewire

• Primary Device ID: 07290015512015
• NIH Device Record Key: 1539c72e-6586-4d99-a5db-76d3f0943b0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wirion System kit Finished Good
• Version Model Number: P2-9-0705-S
• Catalog Number: P2-9-0705-S
• Company DUNS: 531908965
• Company Name: GARDIA MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015512015 [Primary]
GS1	72900155120103 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143570

FDA Product Code

• NTE: Temporary Carotid Catheter For Embolic Capture

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2017-02-12

On-Brand Devices [Wirion System kit Finished Good]

• 07290015512015: The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal
• 72900155120103: The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal