GORE ACUSEAL Cardiovascular Patch Vascular 1CVX004

GUDID 00733132600915

W. L. Gore & Associates, Inc.

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• Primary Device ID: 00733132600915
• NIH Device Record Key: b3898001-41fb-4030-a4e4-d139daf8992a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE ACUSEAL Cardiovascular Patch Vascular
• Version Model Number: 1CVX004
• Catalog Number: 1CVX004
• 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: 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: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter
• Height: 0.5 Centimeter
• Width: 2.5 Centimeter
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984526

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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: 2016-03-07

On-Brand Devices [GORE ACUSEAL Cardiovascular Patch Vascular]

• 00733132600915: 1CVX004
• 00733132600908: 1CVX003
• 00733132600892: 1CVX002