Wirion Retrieval Catheter P4-9-0703

GUDID 72900155120301

The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.

GARDIA MEDICAL LTD

Embolic protection filtering guidewire Embolic protection filtering guidewire Emboli capture 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: 72900155120301
• NIH Device Record Key: fade4bd2-0e60-4d7f-a2e9-897760d6d242
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wirion Retrieval Catheter
• Version Model Number: P4-9-0703
• Catalog Number: P4-9-0703
• 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: false
• 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: info@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	07290015512039 [Primary]
GS1	72900155120301 [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

Devices Manufactured by GARDIA MEDICAL LTD

• 72900155120103 - Wirion System kit Finished Good: 2019-04-09 The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is
• 72900155120202 - Wirion Delivery Catheter: 2019-04-09 The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Delivery Catheter: Contains and del
• 07290015512015 - Wirion System kit Finished Good: 2019-04-09 The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is
• 07290015512022 - Wirion Delivery Catheter: 2019-04-09 The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Delivery Catheter: Contains and deli
• 72900155120301 - Wirion Retrieval Catheter: 2019-04-09The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.
• 72900155120301 - Wirion Retrieval Catheter: 2019-04-09 The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Retrieval Catheter: Retrieves the Filter U