GORE CARDIOFORM Septal Occluder GSX0015A

GUDID 00733132631001

W. L. Gore & Associates, Inc.

Cardiac occluder

• Primary Device ID: 00733132631001
• NIH Device Record Key: 447b3c73-c6fb-42be-9eeb-0a79643d10b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE CARDIOFORM Septal Occluder
• Version Model Number: GSX0015A
• Catalog Number: GSX0015A
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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
• 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

• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132631001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050006

FDA Product Code

• MLV: Transcatheter Septal Occluder

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: 2019-01-28
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE CARDIOFORM Septal Occluder]

• 00733132631032: GSX0030A
• 00733132631025: GSX0025A
• 00733132631018: GSX0020A
• 00733132631001: GSX0015A