GORE DUALMESH PLUS BIOMATERIAL 1DLMCP05

GUDID 00733132601127

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 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 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 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 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: 00733132601127
• NIH Device Record Key: e981883c-6b22-4206-9eaf-537f56aa6c22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE DUALMESH PLUS BIOMATERIAL
• Version Model Number: 1DLMCP05
• Catalog Number: 1DLMCP05
• 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
• 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
• 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

• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter
• Height: 1 Millimeter
• Width: 7.5 Centimeter
• Length: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132601127 [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 DUALMESH PLUS BIOMATERIAL]

• 00733132601219: 1DLMCP204
• 00733132601202: 1DLMCP203
• 00733132601196: 1DLMCP202
• 00733132601189: 1DLMCP201
• 00733132601172: 1DLMCP200
• 00733132601165: 1DLMCP12
• 00733132601158: 1DLMCP08
• 00733132601141: 1DLMCP07
• 00733132601134: 1DLMCP06
• 00733132601127: 1DLMCP05
• 00733132601110: 1DLMCP04
• 00733132601103: 1DLMCP03
• 00733132601097: 1DLMCP02