GORE PRECLUDE Dura Substitute 1PDS152

GUDID 00733132601936

W. L. Gore & Associates, Inc.

Dura mater graft, synthetic
Primary Device ID00733132601936
NIH Device Record Key9a6d90f2-4668-4743-9288-437159858660
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE PRECLUDE Dura Substitute
Version Model Number1PDS152
Catalog Number1PDS152
Company DUNS967358115
Company NameW. L. Gore & Associates, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com

Device Dimensions

Length20 Centimeter
Length20 Centimeter
Length20 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter
Width15 Centimeter
Length20 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132601936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXQDura Substitute

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-07

Devices Manufactured by W. L. Gore & Associates, Inc.

00733132663682 - GORE® VIABAHN® FORTEGRA Venous Stent2026-01-16 FORTEGRA VENOUS STENT 10mm x 50mm
00733132663699 - GORE® VIABAHN® FORTEGRA Venous Stent2026-01-16 FORTEGRA VENOUS STENT 24mm x 75mm
00733132663705 - GORE® VIABAHN® FORTEGRA Venous Stent2026-01-16 FORTEGRA VENOUS STENT 28mm x 150mm
00733132663712 - GORE® VIABAHN® FORTEGRA Venous Stent2026-01-16 FORTEGRA VENOUS STENT 28mm x 100mm
00733132663729 - GORE® VIABAHN® FORTEGRA Venous Stent2026-01-16 FORTEGRA VENOUS STENT 28mm x 75mm
00733132663736 - GORE® VIABAHN® FORTEGRA Venous Stent2026-01-16 FORTEGRA VENOUS STENT 28mm x 50mm
00733132663743 - GORE® VIABAHN® FORTEGRA Venous Stent2026-01-16 FORTEGRA VENOUS STENT 24mm x 150mm
00733132663750 - GORE® VIABAHN® FORTEGRA Venous Stent2026-01-16 FORTEGRA VENOUS STENT 24mm x 100mm

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