GORE ACUSEAL Cardiovascular Patch Vascular 1CVX003

GUDID 00733132600908

W. L. Gore & Associates, Inc.

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Primary Device ID	00733132600908
NIH Device Record Key	7145f9fd-1885-4017-9ab6-a3b948f0be3d
Commercial Distribution Status	In Commercial Distribution
Brand Name	GORE ACUSEAL Cardiovascular Patch Vascular
Version Model Number	1CVX003
Catalog Number	1CVX003
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
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
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

Height	0.5 Centimeter
Height	0.5 Centimeter
Height	0.5 Centimeter
Height	0.5 Centimeter
Height	0.5 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter
Length	7.5 Centimeter
Width	0.8 Centimeter
Height	0.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K984526

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	2016-03-07

On-Brand Devices [GORE ACUSEAL Cardiovascular Patch Vascular]

00733132600915	1CVX004
00733132600908	1CVX003
00733132600892	1CVX002