GORE SYNECOR Biomaterial GKFC12

GUDID 00733132635344

Gore Synecor Intraperitoneal Biomaterial

W. L. Gore & Associates, Inc.

Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer

• Primary Device ID: 00733132635344
• NIH Device Record Key: aa7d0090-d425-4967-9992-8986212b2025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE SYNECOR Biomaterial
• Version Model Number: GKFC12
• Catalog Number: GKFC12
• 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: 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

Device Dimensions

• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter
• Outer Diameter: 12 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132635344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152609

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: 4
• Public Version Date: 2019-01-24
• Device Publish Date: 2016-03-30

On-Brand Devices [GORE SYNECOR Biomaterial]

• 00733132635382: Gore Synecor Intraperitoneal Biomaterial
• 00733132635375: Gore Synecor Intraperitoneal Biomaterial
• 00733132635368: Gore Synecor Intraperitoneal Biomaterial
• 00733132635351: Gore Synecor Intraperitoneal Biomaterial
• 00733132635344: Gore Synecor Intraperitoneal Biomaterial