GORE ACUSEAL Cardiovascular Patch Cardiac 1CVX103

GUDID 00733132600946

W. L. Gore & Associates, Inc.

Cardiovascular patch, synthetic
Primary Device ID00733132600946
NIH Device Record Key3d590f93-e015-4708-a017-eed4efce12f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE ACUSEAL Cardiovascular Patch Cardiac
Version Model Number1CVX103
Catalog Number1CVX103
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
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

Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter
Height0.5 Millimeter
Width3 Centimeter
Length3 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132600946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-29
Device Publish Date2016-03-07

On-Brand Devices [GORE ACUSEAL Cardiovascular Patch Cardiac]

007331326009461CVX103
007331326009391CVX102
007331326009221CVX101

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