GORE PROPATEN Vascular Graft IRTH086060A

GUDID 00733132607464

HEP IR T8MM 60RS X 60CM US

W. L. Gore & Associates, Inc.

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft

• Primary Device ID: 00733132607464
• NIH Device Record Key: 1f0e50d5-249a-41d9-a340-ed161b6f0e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE PROPATEN Vascular Graft
• Version Model Number: IRTH086060A
• Catalog Number: IRTH086060A
• 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: false
• 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
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 60 Centimeter
• Lumen/Inner Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132607464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062161

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE PROPATEN Vascular Graft]

• 00733132617715: HEP SRR 8MMx70CM/8MMx40CM
• 00733132617692: HEP SRR 8MMx90CM/8MMx40CM
• 00733132607488: HEP IR T8MM 80CM RS X 80CM US
• 00733132607464: HEP IR T8MM 60RS X 60CM US
• 00733132607440: HEP IR T8MM 40CM RS X 40CM US
• 00733132607426: HEP IR T7MM 80CM RS X 80CM US
• 00733132607402: HEP IR T7MM 60CM RS X 60CM US
• 00733132607389: HEP IR T7MM 40CM RS X 40CM US
• 00733132607365: HEP IR T6MM 80CM RS X 80CM US
• 00733132607341: HEP IR T6MM 60CM RS X 60CM US
• 00733132607327: HEP IR T6MM 40CM RS X 40CM US
• H373IRH473845A35: HEP IR 4-7MM 38CM RS X 45CM US Propaten Vascular Graft with Integrated Rings
• H373IRH463845A34: HEP IR 4-6MM 38CM RS X 45CM US Propaten Vascular Graft with Integrated Rings
• 00733132607105: HEP IR 6MM 40CM RS X 40CM US Propaten Vascular Graft with Integrated Rings
• 00733132607082: HEP IR 6MM 10CM RS X 20CM US Propaten Vascular Graft with Integrated Rings
• H373IRH060545A3: HEP IR 6MM 5CM RS X 45CM US Propaten Vascular Graft with Integrated Rings
• 00733132607044: HEP IR 6MM 5CM RS X 20CM US Propaten Vascular Graft with Integrated Rings
• 00733132606863: HEP RR T8MM 70CM RS X 90CM US
• 00733132606849: HEP RR T8MM 70CM RS X 80CM US
• 00733132606825: HEP RR T8MM 40CM RS X 50CM US
• 00733132606801: HEP RR T8MM 30CM RS X 40CM US
• 00733132606788: HEP T8MM X 80CM US
• 00733132606764: HEP T8MM X 40CM US
• 00733132606740: HEP RR T7MM 60CM RS X 80CM US
• 00733132606726: HEP T7MM 40CM X 50CM US
• 00733132606702: HEP T7MM X 80CM US
• 00733132606689: HEP T7MM X 40CM US
• 00733132606665: HEP RR T6MM 70CM RS X 90CM US
• 00733132606641: HEP RR T6MM 60CM RS X 80CM US
• 00733132606627: HEP RR T6MM 60CM RS X 70CM US
• 00733132606603: HEP RR T6MM 40CM RS X 50CM US
• 00733132606580: HEP RR T6MM 30CM RS X 70CM US
• 00733132606566: HEP T6MM X 80CM US
• 00733132606542: HEP T6MM X 40CM US
• 00733132606528: HEP RR T5MM 70CM RS X 90CM US
• 00733132606450: HEP RING 6MM 5CM RS X 45CM US
• 00733132605972: HEP 4-7MM X 80CM US
• 00733132605958: HEP 4-7MM X 45CM US
• 00733132605934: HEP 4-6MM X 45CM US
• 00733132605910: HEP 8MM X 80CM US
• 00733132605897: HEP 8MM X 60CM US
• 00733132605873: HEP 8MM X 40CM US
• 00733132605859: HEP 6MM X 80CM US
• 00733132605835: HEP 6MM X 60CM US
• 00733132605811: HEP 6MM X 40CM US
• 00733132605798: HEP 6MM X 10CM US
• 00733132605774: HEP 5MM X 60CM US