GORE BIO-A Hernia Plug HP01

GUDID 00733132606146

GORE BIOABSORB HERNIA PLUG 2PK

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 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: 00733132606146
• NIH Device Record Key: 8474b107-c3f6-4f70-8ecc-a186dbb3be3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE BIO-A Hernia Plug
• Version Model Number: HP01
• Catalog Number: HP01
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 2
• 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: true
• Serial Number: false
• 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

Device Dimensions

• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132606146 [Primary]
GS1	00733132627196 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033671

FDA Product Code

• OWT: Mesh, surgical, absorbable, abdominal hernia

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

On-Brand Devices [GORE BIO-A Hernia Plug]

• 00733132606153: GORE BIOABSORB HERNIA PLUG 1PK
• 00733132606146: GORE BIOABSORB HERNIA PLUG 2PK