GORE BIO-A Tissue Reinforcement FS2030

GUDID H373FS20303

FLAT SHEET 20 X 30 CM - 1PK

W. L. Gore & Associates, Inc.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: H373FS20303
• NIH Device Record Key: c2af227f-8fa0-4925-a94f-4e6b2ba2836f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE BIO-A Tissue Reinforcement
• Version Model Number: FS2030
• Catalog Number: FS2030
• 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: 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
• 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
• 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
• 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
• 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

• Length: 30 Centimeter
• Length: 30 Centimeter
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• Width: 20 Centimeter
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• Length: 30 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132605453 [Primary]
HIBCC	H373FS20303 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033671

FDA Product Code

• OWZ: Mesh, surgical, absorbable, thoracic, chest wall reconstruction

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: 2019-10-28
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE BIO-A Tissue Reinforcement]

• 00733132606139: FLAT SHEET 7 X 10 CM - 1PK
• H373FS20303: FLAT SHEET 20 X 30 CM - 1PK
• 00733132605446: FLAT SHEET 20 X 20 CM - 1PK
• 00733132605439: FLAT SHEET 10 X 30 CM - 1PK
• H373FS091533: FLAT SHEET 9 X 15 CM - 1PK
• H373FS080834: FLAT SHEET 8 X 8 CM - 1PK