GORE SYNECOR Biomaterial GKFR2025

GUDID 00733132635351

Gore Synecor Intraperitoneal Biomaterial

W. L. Gore & Associates, Inc.

Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer

Primary Device ID	00733132635351
NIH Device Record Key	43651581-9f67-44c0-9d25-355017f0d8fa
Commercial Distribution Status	In Commercial Distribution
Brand Name	GORE SYNECOR Biomaterial
Version Model Number	GKFR2025
Catalog Number	GKFR2025
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	true
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

Device Dimensions

Width	20 Centimeter
Width	20 Centimeter
Width	20 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter
Length	25 Centimeter
Width	20 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132635351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152609

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	2019-01-24
Device Publish Date	2016-03-30

On-Brand Devices [GORE SYNECOR Biomaterial]

00733132635382	Gore Synecor Intraperitoneal Biomaterial
00733132635375	Gore Synecor Intraperitoneal Biomaterial
00733132635368	Gore Synecor Intraperitoneal Biomaterial
00733132635351	Gore Synecor Intraperitoneal Biomaterial
00733132635344	Gore Synecor Intraperitoneal Biomaterial