GORE DUALMESH Biomaterial 1DLMC04

GUDID 00733132600977

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: 00733132600977
• NIH Device Record Key: e8ecb582-0fe7-4893-9d73-07f0ceb7017b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE DUALMESH Biomaterial
• Version Model Number: 1DLMC04
• Catalog Number: 1DLMC04
• 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
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 19 Centimeter
• Length: 19 Centimeter
• Length: 19 Centimeter
• Length: 19 Centimeter
• Length: 19 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter
• Height: 1 Millimeter
• Width: 15 Centimeter
• Length: 19 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992189

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: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-03-07

On-Brand Devices [GORE DUALMESH Biomaterial]

• 00733132601073: 1DLMC204
• 00733132601066: 1DLMC203
• 00733132601059: 1DLMC202
• 00733132601042: 1DLMC201
• 00733132601035: 1DLMC200
• 00733132601028: 1DLMC09
• 00733132601011: 1DLMC08
• 00733132601004: 1DLMC07
• 00733132600991: 1DLMC06
• 00733132600984: 1DLMC05
• 00733132600977: 1DLMC04
• 00733132600960: 1DLMC03
• 00733132600953: 1DLMC02