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

• 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