GORE-TEX Cardiovascular Patch 1705015006

GUDID 00733132600663

STP 5.0 CM X 15.0 CM X .6 MM

W. L. Gore & Associates, Inc.

Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic

Primary Device ID	00733132600663
NIH Device Record Key	4981cdba-0bb8-4148-b185-73d5cc1fc9ec
Commercial Distribution Status	In Commercial Distribution
Brand Name	GORE-TEX Cardiovascular Patch
Version Model Number	1705015006
Catalog Number	1705015006
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	5 Centimeter
Width	5 Centimeter
Width	5 Centimeter
Width	5 Centimeter
Width	5 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter
Height	0.6 Millimeter
Length	15 Centimeter
Width	5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600663 [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