GORE Embolic Filter GEFA017185

GUDID 00733132618255

7MM FILTER ON 185CM GUIDEWIRE

W. L. Gore & Associates, Inc.

Embolic protection filtering guidewire

• Primary Device ID: 00733132618255
• NIH Device Record Key: be389bfe-3c9a-4c5e-8876-5634bd8620c5
• Commercial Distribution Discontinuation: 2019-12-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GORE Embolic Filter
• Version Model Number: GEFA017185
• Catalog Number: GEFA017185
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• 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: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 185 Centimeter
• Length: 185 Centimeter
• Length: 185 Centimeter
• Length: 185 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132618255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103500

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: 6
• Public Version Date: 2019-12-12
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE Embolic Filter]

• 00733132618286: 7MM FILTER ON 300CM GUIDEWIRE
• 00733132618279: 5MM FILTER ON 185CM GUIDEWIRE
• H373GEFA01530039: 5MM FILTER ON 300CM GUIDEWIRE
• 00733132618255: 7MM FILTER ON 185CM GUIDEWIRE