Heli-FX™ EndoAnchor™ System

GUDID 00763000645137

GUIDE HG-16-62-28 AAA ENDOANCH 28 EIFU

MEDTRONIC VASCULAR, INC.

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 00763000645137
• NIH Device Record Key: 6f3270c3-b1aa-4731-accc-deafa6691b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heli-FX™ EndoAnchor™ System
• Version Model Number: HG-16-62-28
• Company DUNS: 080009661
• Company Name: MEDTRONIC VASCULAR, 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter
• Length: 28 Millimeter
• Outer Diameter: 5.3 Millimeter
• Length: 62 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000645137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182957

FDA Product Code

• OTD: Endovascular suturing system

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-31
• Device Publish Date: 2022-10-22

Devices Manufactured by MEDTRONIC VASCULAR, INC.

• 00763000645137 - Heli-FX™ EndoAnchor™ System: 2022-10-31GUIDE HG-16-62-28 AAA ENDOANCH 28 EIFU
• 00763000645137 - Heli-FX™ EndoAnchor™ System: 2022-10-31 GUIDE HG-16-62-28 AAA ENDOANCH 28 EIFU
• 00763000645144 - Heli-FX™ Thoracic EndoAnchor™ System: 2022-10-31 ACC HA-18-114 TAA APPL-CASS 10 EIFU US
• 00763000645151 - Heli-FX™ Thoracic EndoAnchor™ System: 2022-10-31 GUIDE HG-18-90-22 TAA ENDOANCH 22 EIFU
• 00763000645168 - Heli-FX™ Thoracic EndoAnchor™ System: 2022-10-31 GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU
• 00763000645175 - Heli-FX™ Thoracic EndoAnchor™ System: 2022-10-31 GUIDE HG-18-90-42 TAA ENDOANCH 42 EIFU
• 00763000645182 - Heli-FX™ Ancillary EndoAnchor™ Cassette: 2022-10-31 ACC EC-05 ANCIL ENDOANCH CASS EIFU US
• 00643169647565 - APTUS Heli-FX®: 2020-05-06 GUIDE HG-18-90-42 TAA ENDOANCH 90CM MDT
• 00643169647572 - APTUS Heli-FX®: 2020-05-06 GUIDE SG-64 AAA ENDOANCHOR 62CM MDT