Heli-FX™ EndoAnchor™ System

GUDID 00763000025250

AAA GUIDE DEVICE 22 EIFU

MEDTRONIC, INC.

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 00763000025250
• NIH Device Record Key: 6e4800c3-4499-46a3-b425-0e7706453018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heli-FX™ EndoAnchor™ System
• Version Model Number: SG-64
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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

Device Dimensions

• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter

Operating and Storage Conditions

• 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	00763000025250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171427

FDA Product Code

• OTD: Endovascular suturing system

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: 2020-05-06
• Device Publish Date: 2017-11-10

On-Brand Devices [Heli-FX™ EndoAnchor™ System]

• 00763000025298: TAA GUIDE DEVICE 42 EIFU
• 00763000025281: TAA GUIDE DEVICE 32 EIFU
• 00763000025274: TAA GUIDE DEVICE 22 EIFU
• 00763000025267: AAA GUIDE DEVICE 28 EIFU
• 00763000025250: AAA GUIDE DEVICE 22 EIFU
• 00763000006686: ANCILLARY ENDOANCHOR CASSETTE US
• 00763000006679: TAA GUIDE DEVICE 42 EIFU
• 00763000006662: TAA GUIDE DEVICE 32 EIFU
• 00763000006655: TAA GUIDE DEVICE 22 EIFU
• 00763000006648: TAA APPLIER DEVICE US EIFU
• 00763000006631: AAA GUIDE DEVICE 28 EIFU
• 00763000006624: AAA GUIDE DEVICE 22 EIFU
• 00763000006617: AAA APPLIER DEVICE US EIFU
• 00763000225971: GUIDE HG-16-62-28 AAA ENDOANCH 28 EIFU
• 00763000225964: GUIDE SG-64 AAA ENDOANCHOR EIFU
• 00763000226008: GUIDE HG-18-90-42 TAA ENDOANCH 42 EIFU
• 00763000225995: GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU
• 00763000225988: GUIDE HG-18-90-22 TAA ENDOANCH 22 EIFU
• 00763000225940: ACC HA-18-114 TAA APPL-CASS 10 EIFU US
• 00763000225933: ACC SA-85 AAA APPL-CASSETTE 10 EIFU US
• 00763000225957: ACC EC-05 ANCIL ENDOANCHOR CASSETTE US
• 00763000645120: GUIDE SG-64 AAA ENDOANCHOR 22 EIFU US
• 00763000645113: ACC SA-85 AAA APPL-CASSETTE 10 EIFU US