GORE-TEX Cardiovascular Patch

Basic Information

• Brand Name: GORE-TEX Cardiovascular Patch
• Primary DI: 00733132600731
• Version / Model: 1905007508
• Catalog Number: 1905007508
• Company Name: W. L. Gore & Associates, Inc.
• Labeler DUNS: 967358115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-27
• Public Version: 7
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: 451b4c4a-245e-4a81-a2a8-24bd7b2dbe96

Device Description

GORE-TEX CARDIOVASCULAR PATCH 5.0cmX7.5cmX0.8mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	870.3470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31744	Cardiovascular patch, synthetic	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733132600731	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K912107	000

Device Sizes

Type	Value	Unit	Text
Width	5.0	Centimeter
Length	7.5	Centimeter
Height	0.8	Millimeter