GORE SYNECOR Preperitoneal Biomaterial GKWC09

GUDID 00733132653744

GORE SYNECOR PREPERITONEAL 9CM Circular 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 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

• Primary Device ID: 00733132653744
• NIH Device Record Key: 2020528b-9216-4de1-b6c4-b41210fd30ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE SYNECOR Preperitoneal Biomaterial
• Version Model Number: GKWC09
• Catalog Number: GKWC09
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Dimensions

• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter
• Outer Diameter: 9 Centimeter
• Depth: 0.75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132653744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163576

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-13
• Device Publish Date: 2021-10-05

On-Brand Devices [GORE SYNECOR Preperitoneal Biomaterial]

• 00733132638758: Comp PP 15cm x 20cm Oval
• 00733132638741: Comp PP 10cm x 15cm Oval
• 00733132638734: Comp PP 20cm x 30cm Rectangle
• 00733132638727: Comp PP 20cm x 25cm Rectangle
• 00733132638710: Comp PP 12cm x 15cm Rectangle
• 00733132653744: GORE SYNECOR PREPERITONEAL 9CM Circular Biomaterial
• 00733132653737: GORE SYNECOR PREPERITONEAL 30cmX40cmRectangle Biomaterial
• 00733132653720: GORE SYNECOR PREPERITONEAL 35cmX35cmRectangle Biomaterial
• 00733132653713: GORE SYNECOR PREPERITONEAL 40cmX50cmRectangle Biomaterial
• 00733132653706: GORE SYNECOR PREPERITONEAL 30cmX30cmRectangle Biomaterial
• 00733132653690: GORE SYNECOR PREPERITONEAL 40cmX40cmRectangle Biomaterial