GORE MYCROMESH PLUS Biomaterial 1MYMP08

GUDID 00733132601660

W. L. Gore & Associates, Inc.

Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial

• Primary Device ID: 00733132601660
• NIH Device Record Key: 86aa8a97-b0fc-4754-ba34-6a36ff0937a4
• Commercial Distribution Discontinuation: 2018-01-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GORE MYCROMESH PLUS Biomaterial
• Version Model Number: 1MYMP08
• Catalog Number: 1MYMP08
• 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: 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

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132601660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063435

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-07

On-Brand Devices [GORE MYCROMESH PLUS Biomaterial]

• 00733132601721: 1MYMP18
• 00733132601714: 1MYMP17
• 00733132601707: 1MYMP16
• 00733132601691: 1MYMP15
• 00733132601684: 1MYMP10
• 00733132601677: 1MYMP09
• 00733132601660: 1MYMP08
• 00733132601653: 1MYMP07
• 00733132601646: 1MYMP06
• 00733132601622: 1MYMP02
• 00733132601615: 1MYMP01