Gore Septal Occluder GSXA0015

GUDID 00733132617609

GORE SEPTAL OCCLUDER 15MM ASD

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
Primary Device ID00733132617609
NIH Device Record Key86f0503d-c927-4c3a-9bf2-f5715c5a4384
Commercial Distribution Discontinuation2018-08-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGore Septal Occluder
Version Model NumberGSXA0015
Catalog NumberGSXA0015
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 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

Device Dimensions

Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter
Catheter Gauge10 French
Outer Diameter15 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Out of Direct Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132617609 [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 Number5
Public Version Date2018-10-31
Device Publish Date2017-02-13

Devices Manufactured by W. L. Gore & Associates, Inc.

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