GORE-TEX Soft Tissue Patch 140501001B

GUDID 00733132600571

STP 5.0 CM X 10.0 CM X 1.0 MM

W. L. Gore & Associates, Inc.

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 00733132600571
• NIH Device Record Key: f9ecce35-b847-47eb-b1b7-819d8739adf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Soft Tissue Patch
• Version Model Number: 140501001B
• Catalog Number: 140501001B
• 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: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: 800-528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Height: 1 Millimeter
• Height: 1 Millimeter
• Height: 1 Millimeter
• Height: 1 Millimeter
• Height: 1 Millimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963619

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: 5
• Public Version Date: 2019-09-05
• Device Publish Date: 2017-01-26

On-Brand Devices [GORE-TEX Soft Tissue Patch]

• 00733132600625: STP 26.0 CM X 34.0 CM X 1.0 MM
• 00733132600618: STP 20.0 CM X 30.0 CM X 1.0 MM
• 00733132600601: STP 15.0 CM X 20.0 CM X 1.0 MM
• 00733132600595: STP 10.0 CM X 15.0 CM X 1.0 MM
• 00733132600588: STP 5.0 CM X 15.0 CM X 1.0 MM
• 00733132600571: STP 5.0 CM X 10.0 CM X 1.0 MM
• 00733132600564: STP 5.0 CM X 10.0 CM X 1.0 MM
• 00733132600540: STP 26.0 CM X 34.0 CM X 2.0 MM
• 00733132600533: STP 20.0 CM X 30.0 CM X 2.0 MM
• 00733132600526: STP 15.0 CM X 20.0 CM X 2.0 MM
• 00733132600519: STP 10.0 CM X 15.0 CM X 2.0 MM
• 00733132600502: STP 5.0 CM X 15.0 CM X 2.0 MM
• 00733132600489: STP 5.0 CM X 10.0 CM X 2.0 MM