GORE-TEX Cardiovascular Patch 1802014004

GUDID 00733132600700

STP 2.0 CM X 14.0 CM X .4 MM

W. L. Gore & Associates, Inc.

Cardiovascular patch, synthetic

• Primary Device ID: 00733132600700
• NIH Device Record Key: 98c1d681-fe42-4b07-af2e-60f398c16a9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Cardiovascular Patch
• Version Model Number: 1802014004
• Catalog Number: 1802014004
• 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: 2 Centimeter
• Width: 2 Centimeter
• Width: 2 Centimeter
• Width: 2 Centimeter
• Width: 2 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter
• Height: 0.4 Millimeter
• Length: 9 Centimeter
• Width: 2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600700 [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