GORE-TEX Soft Tissue Patch 142603401A

GUDID 00733132600625

STP 26.0 CM X 34.0 CM X 1.0 MM

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	00733132600625
NIH Device Record Key	c5520788-1da0-4a78-9882-9747142aeb0d
Commercial Distribution Status	In Commercial Distribution
Brand Name	GORE-TEX Soft Tissue Patch
Version Model Number	142603401A
Catalog Number	142603401A
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	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com
Phone	800-528-8763
Email	mpdcustomercare@wlgore.com

Device Dimensions

Width	26 Centimeter
Width	26 Centimeter
Width	26 Centimeter
Width	26 Centimeter
Width	26 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter
Height	1 Millimeter
Length	34 Centimeter
Width	26 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132600625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K963619

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	5
Public Version Date	2019-09-05
Device Publish Date	2017-01-27

On-Brand Devices [GORE-TEX Soft Tissue Patch]

00733132600625	STP 26.0 CM X 34.0 CM X 1.0 MM
00733132600618	STP 20.0 CM X 30.0 CM X 1.0 MM
00733132600601	STP 15.0 CM X 20.0 CM X 1.0 MM
00733132600595	STP 10.0 CM X 15.0 CM X 1.0 MM
00733132600588	STP 5.0 CM X 15.0 CM X 1.0 MM
00733132600571	STP 5.0 CM X 10.0 CM X 1.0 MM
00733132600564	STP 5.0 CM X 10.0 CM X 1.0 MM
00733132600540	STP 26.0 CM X 34.0 CM X 2.0 MM
00733132600533	STP 20.0 CM X 30.0 CM X 2.0 MM
00733132600526	STP 15.0 CM X 20.0 CM X 2.0 MM
00733132600519	STP 10.0 CM X 15.0 CM X 2.0 MM
00733132600502	STP 5.0 CM X 15.0 CM X 2.0 MM
00733132600489	STP 5.0 CM X 10.0 CM X 2.0 MM