GORE ACUSEAL Vascular Graft ECH060040A

GUDID H373ECH060040A38

ACUSEAL 6MM X 40CM 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: H373ECH060040A38
• NIH Device Record Key: 37ce9c31-b2d6-428f-8148-90489bb836fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE ACUSEAL Vascular Graft
• Version Model Number: ECH060040A
• Catalog Number: ECH060040A
• 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: 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
• 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: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132605354 [Primary]
HIBCC	H373ECH060040A38 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130215

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: 2018-10-29
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE ACUSEAL Vascular Graft]

• 00733132634811: ACUSEAL 4-6MM X 45CM US
• 00733132626984: ACUSEAL 4-7MM X 45CM US
• 00733132626960: ECH060050A
• 00733132622597: ACUSEAL 6MM X 20CM US
• 00733132622573: ACUSEAL 6MM X 10CM US
• H373ECH060040A38: ACUSEAL 6MM X 40CM US