GORE PROPATEN Vascular Graft Pediatric Shunt HPT050010A

GUDID 00733132606337

HEP PED SHUNT T5MM X 10CM 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 Synthetic vascular graft

• Primary Device ID: 00733132606337
• NIH Device Record Key: 0a59afe4-7c93-43a1-99f7-56c70b45ae7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE PROPATEN Vascular Graft Pediatric Shunt
• Version Model Number: HPT050010A
• Catalog Number: HPT050010A
• 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
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132606337 [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 Pediatric Shunt]

• H373HPT350015A3: HEP PED SHUNT T3.5MM X 15CM US
• 00733132606412: HEP PED SHUNT T3.5MM X 10CM US
• H373HPT350005A3: HEP PED SHUNT T3.5MM X 5CM US
• H373HPT060015A3: HEP PED SHUNT T6MM X 15CM US
• H373HPT050015A3: HEP PED SHUNT T5MM X 15CM US
• 00733132606337: HEP PED SHUNT T5MM X 10CM US
• H373HPT050005A3: HEP PED SHUNT T5MM X 5CM US
• H373HPT040015A3: HEP PED SHUNT T4MM X 15CM US
• 00733132606276: HEP PED SHUNT T4MM X 10CM US
• 00733132606252: HEP PED SHUNT T4MM X 5CM US
• 00733132606238: HEP PED SHUNT T3MM X 15CM US
• 00733132606214: HEP PED SHUNT T3MM X 10CM
• 00733132606191: HEP PED SHUNT T3MM X 5CM US