GORE PRECLUDE PDX Dura Substitute 1PDX305

GUDID 00733132601981

PDX 2.0 CM X 3.0 CM X 0.3 MM

W. L. Gore & Associates, Inc.

Dura mater graft, synthetic

• Primary Device ID: 00733132601981
• NIH Device Record Key: 83c1d271-1311-4c10-8a0b-5fd6d2105f3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE PRECLUDE PDX Dura Substitute
• Version Model Number: 1PDX305
• Catalog Number: 1PDX305
• 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: +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

• Width: 2 Centimeter
• Width: 2 Centimeter
• Width: 2 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter
• Length: 3 Centimeter
• Width: 2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132601981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984534

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: 2017-02-13

On-Brand Devices [GORE PRECLUDE PDX Dura Substitute]

• 00733132602001: 1PDX307
• 00733132601998: 1PDX306
• 00733132601981: PDX 2.0 CM X 3.0 CM X 0.3 MM
• 00733132601974: 1PDX303
• 00733132601967: 1PDX302
• 00733132601950: 1PDX301
• 00733132601943: 1PDX300