GORE PRECLUDE MVP Dura Substitute 1MVP401

GUDID 00733132601462

MVP 5 CM X 6 CM

W. L. Gore & Associates, Inc.

Dura mater graft, synthetic

• Primary Device ID: 00733132601462
• NIH Device Record Key: 4f065ab4-ee24-42e5-8a4a-b5123e584faf
• Commercial Distribution Discontinuation: 2016-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GORE PRECLUDE MVP Dura Substitute
• Version Model Number: 1MVP401
• Catalog Number: 1MVP401
• 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

Device Dimensions

• Width: 5 Centimeter
• Width: 5 Centimeter
• Width: 5 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter
• Length: 6 Centimeter
• Width: 5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132601462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021477

FDA Product Code

• GXQ: Dura Substitute

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-29

On-Brand Devices [GORE PRECLUDE MVP Dura Substitute]

• 00733132601493: MVP 4 CM X 4 CM
• 00733132601486: MVP 10 CM X 12 CM
• 00733132601479: MVP 6 CM X 10 CM
• 00733132601462: MVP 5 CM X 6 CM
• 00733132601455: MVP 2 CM X 10 CM