GORE EXCLUDER Iliac Branch Endoprosthesis HGB161407A

GUDID 00733132635337

Internal Iliac

W. L. Gore & Associates, Inc.

Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft

• Primary Device ID: 00733132635337
• NIH Device Record Key: 60e674de-2623-4485-9cdf-a54c70a85f0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE EXCLUDER Iliac Branch Endoprosthesis
• Version Model Number: HGB161407A
• Catalog Number: HGB161407A
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French
• Length: 7 Centimeter
• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 14.5 Millimeter
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132635337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020004

FDA Product Code

• MIH: System, Endovascular Graft, Aortic Aneurysm Treatment

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: 2019-01-24
• Device Publish Date: 2016-04-22

On-Brand Devices [GORE EXCLUDER Iliac Branch Endoprosthesis]

• 00733132635337: Internal Iliac
• 00733132635320: Internal Iliac
• 00733132635313: Internal Iliac
• 00733132635306: Branch Component
• 00733132635290: Branch Component
• 00733132635283: Branch Component