Gore Septal Occluder GSXA0015

GUDID 00733132617609

GORE SEPTAL OCCLUDER 15MM ASD

W. L. Gore & Associates, Inc.

Cardiac occluder

• Primary Device ID: 00733132617609
• NIH Device Record Key: 86f0503d-c927-4c3a-9bf2-f5715c5a4384
• Commercial Distribution Discontinuation: 2018-08-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Gore Septal Occluder
• Version Model Number: GSXA0015
• Catalog Number: GSXA0015
• 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: 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

Device Dimensions

• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter
• Catheter Gauge: 10 French
• Outer Diameter: 15 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Direct Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132617609 [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: 5
• Public Version Date: 2018-10-31
• Device Publish Date: 2017-02-13

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