GORE-TEX Vascular Graft Pediatric Shunt ST04010A

GUDID H373ST04010A3H

STR T4MM X 10CM SILK STRETCH

W. L. Gore & Associates, Inc.

Synthetic vascular graft

• Primary Device ID: H373ST04010A3H
• NIH Device Record Key: 08d9db7e-d130-4e15-a338-c706c67d9cfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Vascular Graft Pediatric Shunt
• Version Model Number: ST04010A
• Catalog Number: ST04010A
• 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: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132612536 [Primary]
HIBCC	H373ST04010A3H [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: 2019-01-25
• Device Publish Date: 2017-01-10

On-Brand Devices [GORE-TEX Vascular Graft Pediatric Shunt]

• H373ST04015A3M: STR T4MM X 15CM SILK STRETCH
• H373ST04010A3H: STR T4MM X 10CM SILK STRETCH
• H373ST03015A3L: STR T3MM X 15CM SILK STRETCH
• H373ST03010A3G: STR T3MM X 10CM SILK STRETCH