GORE CARDIOFORM Septal Occluder GSX0025A

GUDID 00733132631025

W. L. Gore & Associates, Inc.

Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder
Primary Device ID00733132631025
NIH Device Record Keye38c5511-fc30-45ea-a260-736e8a65478c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE CARDIOFORM Septal Occluder
Version Model NumberGSX0025A
Catalog NumberGSX0025A
Company DUNS967358115
Company NameW. L. Gore & Associates, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
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

Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French
Device Size Text, specify0
Outer Diameter25 Millimeter
Catheter Gauge10 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132631025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLVTranscatheter Septal Occluder

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-28
Device Publish Date2017-02-13

On-Brand Devices [GORE CARDIOFORM Septal Occluder]

00733132631032GSX0030A
00733132631025GSX0025A
00733132631018GSX0020A
00733132631001GSX0015A

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