GORE HELEX Septal Occluder

GUDID H373HX20203

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 ID: H373HX20203
• NIH Device Record Key: 4a42f41a-8786-415c-97d4-bd4ac41a2643
• Commercial Distribution Discontinuation: 2016-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GORE HELEX Septal Occluder
• Version Model Number: HX2020
• 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

• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 20 Millimeter
• Length: 75 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132606986 [Primary]
HIBCC	H373HX20203 [Secondary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE HELEX Septal Occluder]

• H373HX203535: HX2035
• H373HX203030: HX2030
• H373HX202534: HX2025
• H373HX20203: HX2020
• H373HX201533: HX2015