GORE-TEX Vascular Graft Pediatric Shunt VT04010LA

GUDID H373VT04010LA3

VG T4MM X 10CM SILK

W. L. Gore & Associates, Inc.

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• Primary Device ID: H373VT04010LA3
• NIH Device Record Key: 917de3f9-33b8-42ec-8b87-4cf2bcac166d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Vascular Graft Pediatric Shunt
• Version Model Number: VT04010LA
• Catalog Number: VT04010LA
• 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	00733132615865 [Primary]
HIBCC	H373VT04010LA3 [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: 2019-01-24
• Device Publish Date: 2017-02-13

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

• H373VT35010LA32: VG T3.5MM X 10CM SILK
• H373VT35005LA36: VG T3.5MM X 5CM SILK
• H373VT05010LA3: VG T5MM X 10CM SILK
• H373VT04010LA3: VG T4MM X 10CM SILK
• H373VT03010LA3: VG T3MM X 10CM SILK