GORE PRECLUDE PDX Dura Substitute 1PDX300

GUDID 00733132601943

W. L. Gore & Associates, Inc.

Dura mater graft, synthetic

• Primary Device ID: 00733132601943
• NIH Device Record Key: 75d72636-2c4a-4e56-9458-1471cf639886
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE PRECLUDE PDX Dura Substitute
• Version Model Number: 1PDX300
• Catalog Number: 1PDX300
• 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

Device Dimensions

• Width: 2 Centimeter
• Width: 2 Centimeter
• Width: 2 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter
• Length: 10 Centimeter
• Width: 2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132601943 [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: 4
• Public Version Date: 2019-01-24
• Device Publish Date: 2016-03-07

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