GORE TAG Conformable Thoracic Stent Graft TGMR313115

GUDID 00733132646784

31mmX31mmX15cm 20Fr

W. L. Gore & Associates, Inc.

Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft

• Primary Device ID: 00733132646784
• NIH Device Record Key: d9c1a290-2615-4b2f-a9f5-4b0a088478d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE TAG Conformable Thoracic Stent Graft
• Version Model Number: TGMR313115
• Catalog Number: TGMR313115
• 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: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter
• Catheter Gauge: 20 French
• Outer Diameter: 31 Millimeter
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132646784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040043

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-17
• Device Publish Date: 2019-06-07

On-Brand Devices [GORE TAG Conformable Thoracic Stent Graft]

• 00733132647002: 45mmX45mmX20cm 24Fr
• 00733132646999: 45mmX45mmX15cm 24Fr
• 00733132646982: 45mmX45mmX10cm 24Fr
• 00733132646975: 34mmX34mmX20cm 22Fr
• 00733132646968: 34mmX34mmX15cm 22Fr
• 00733132646951: 34mmX34mmX10cm 22Fr
• 00733132646944: 28mmX28mmX15cm 20Fr
• 00733132646937: 28mmX28mmX10cm 20Fr
• 00733132646920: 26mmX26mmX10cm 20Fr
• 00733132646913: 26mmX21mmX10cm 20Fr
• 00733132646890: 21mmX21mmX10cm 18Fr
• 00733132646852: 40mmX40mmX20cm 22Fr
• 00733132646845: 40mmX40mmX15cm 22Fr
• 00733132646838: 40mmX40mmX10cm 22Fr
• 00733132646821: 37mmX37mmX20cm 22Fr
• 00733132646814: 37mmX37mmX15cm 22Fr
• 00733132646807: 37mmX37mmX10cm 22Fr
• 00733132646791: 31mmX31mmX20cm 20Fr
• 00733132646784: 31mmX31mmX15cm 20Fr
• 00733132646777: 31mmX31mmX10cm 20Fr
• 00733132646760: 31mmX26mmX10cm 20Fr