GORE BIO-A Fistula Plug FP0616

GUDID H373FP06163

FISTULA PLUG 16MMD 6X9CMT 1PK

W. L. Gore & Associates, Inc.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: H373FP06163
• NIH Device Record Key: d14e66c0-4569-4293-8f52-f8d6f763e11e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE BIO-A Fistula Plug
• Version Model Number: FP0616
• Catalog Number: FP0616
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Length: 9 Centimeter
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132605408 [Primary]
HIBCC	H373FP06163 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083266

FDA Product Code

• FTL: Mesh, surgical, polymeric

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

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

• 00733132661664 - GORE TAG Conformable Thoracic Stent Graft: 2025-03-26 CTAG CMDS 34MMX28MMX15CM 22Fr
• 00733132661671 - GORE TAG Conformable Thoracic Stent Graft: 2025-03-26 CTAG CMDS 45MMX37MMX15CM 24Fr
• 00733132661688 - GORE TAG Conformable Thoracic Stent Graft: 2025-03-26 CTAG CMDS 37MMX31MMX15CM 22Fr
• 00733132661695 - GORE TAG Conformable Thoracic Stent Graft: 2025-03-26 CTAG CMDS 40MMX34MMX15CM 22Fr
• 00733132658855 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx10Fr
• 00733132658862 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 45cmx10Fr
• 00733132658879 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 65cmx10Fr
• 00733132658886 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx11Fr