AccessGUDID - DEVICE: GORE TAG Thoracic Branch Endoprosthesis (00733132654192)

GUDID

Device Identifier (DI) Information

Brand Name: GORE TAG Thoracic Branch Endoprosthesis
Version or Model: TAC123415A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TAC123415A
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132654192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: TAG TBE AORTIC COMPONENT TAG TBE AC 12MMX34MMX15CM

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P210032	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 24 French
Length: 15 Centimeter
Lumen/Inner Diameter: 34 Millimeter

Device Record Status

Public Device Record Key: 65bc15ae-4f37-4ece-b9b9-1fb945d442e2
Public Version Date: August 29, 2023
Public Version Number: 2
DI Record Publish Date: June 27, 2022