GORE ACUSEAL Cardiovascular Patch Cardiac 1CVX101

GUDID 00733132600922

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 Cardiovascular patch, synthetic

Primary Device ID	00733132600922
NIH Device Record Key	15919aa0-00e8-444b-8da6-fdb0989c03de
Commercial Distribution Status	In Commercial Distribution
Brand Name	GORE ACUSEAL Cardiovascular Patch Cardiac
Version Model Number	1CVX101
Catalog Number	1CVX101
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

Length	6 Centimeter
Length	6 Centimeter
Length	6 Centimeter
Length	6 Centimeter
Length	6 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter
Height	0.5 Millimeter
Width	3 Centimeter
Length	6 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600922 [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 Cardiac]

00733132600946	1CVX103
00733132600939	1CVX102
00733132600922	1CVX101