GORE TAG Thoracic Branch Endoprosthesis

Basic Information

• Brand Name: GORE TAG Thoracic Branch Endoprosthesis
• Primary DI: 00733132654079
• Version / Model: TAC083115A
• Catalog Number: TAC083115A
• 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: 2022-06-24
• Public Version: 2
• Public Version Date: 2023-08-29
• Public Version Status: Update
• Public Device Record Key: fdf62c1d-5d5d-48b3-b6da-62a8c6ae7f53

Device Description

TAG TBE THORACIC AORTIC BRANCH 31mmX15cm 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: MR Conditional
• 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
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62573	Aortic arch endovascular stent-graft	A non-bioabsorbable tubular device intended for endovascular implantation, in a modular configuration, to repair lesions of the aortic arch and descending thoracic aorta. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). It includes a docking portal(s) for attachment of an ancillary endovascular stent-graft(s) [not included] to occupy and allow flow to an aortic arch branch vessel(s). It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733132654079	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P210032	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	22	French
Length	15	Centimeter
Lumen/Inner Diameter	31	Millimeter