GORE-TEX STRETCH Vascular Graft Pediatric Shunt ST03005A

GUDID H373ST03005A3K

STR T3MM X 5CM SILK

W. L. Gore & Associates, Inc.

Synthetic vascular graft

• Primary Device ID: H373ST03005A3K
• NIH Device Record Key: dacbca5e-0d95-4d43-a25b-55d5b6f6815e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX STRETCH Vascular Graft Pediatric Shunt
• Version Model Number: ST03005A
• Catalog Number: ST03005A
• 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: 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: +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

• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132612505 [Primary]
HIBCC	H373ST03005A3K [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013250

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: 4
• Public Version Date: 2019-01-28
• Device Publish Date: 2017-01-10

Devices Manufactured by W. L. Gore & Associates, Inc.

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• 00733132658879 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 65cmx10Fr
• 00733132658886 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx11Fr
• 00733132658893 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath Ao 33cmx12Fr
• 00733132658909 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath Ao 45cmx12Fr
• 00733132658916 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath IC 65cmx12Fr
• 00733132658923 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath Ao 33cmx14Fr