GORE-TEX Cardiovascular Patch 1910015008

GUDID 00733132600748

STP 10.0 CM X 15.0 CM X 0.8 MM

W. L. Gore & Associates, Inc.

Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic

• Primary Device ID: 00733132600748
• NIH Device Record Key: 01debebb-41a8-4bdd-a1ff-8c73d140049c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Cardiovascular Patch
• Version Model Number: 1910015008
• Catalog Number: 1910015008
• 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: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Width: 10 Centimeter
• Width: 10 Centimeter
• Width: 10 Centimeter
• Width: 10 Centimeter
• Width: 10 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Height: 0.8 Millimeter
• Length: 15 Centimeter
• Width: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912107

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: 2017-01-27

On-Brand Devices [GORE-TEX Cardiovascular Patch]

• 00733132600748: STP 10.0 CM X 15.0 CM X 0.8 MM
• 00733132600731: STP 5.0 CM X 7.5 CM X 0.8 MM
• 00733132600724: STP 3.0 CM X 6.0 CM X .4 MM
• 00733132600717: STP 3.0 CM X 3.0 CM X .4 MM
• 00733132600700: STP 2.0 CM X 14.0 CM X .4 MM
• 00733132600694: STP 2.0 CM X 9.0 CM X .4 MM
• 00733132600687: STP .6 CM X 10.0 CM X .4 MM
• 00733132600670: STP 10.0 CM X 15.0 CM X .6 MM
• 00733132600663: STP 5.0 CM X 15.0 CM X .6 MM
• 00733132600656: STP 5.0 CM X 7.5 CM X .6 MM
• 00733132600649: STP 2.5 CM X 15.0 CM X .6 MM
• 00733132600632: STP 2.5 CM X 3.8 CM X .6 MM