AccessGUDID - DEVICE: GORE TAG Thoracic Branch Endoprosthesis (00733132654406)

GUDID

Device Identifier (DI) Information

Brand Name: GORE TAG Thoracic Branch Endoprosthesis
Version or Model: TSB121506A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSB121506A
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132654406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: TAG TBE THORACIC SIDE BRANCH 15mmX6cm 12mm Heparin

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:	Yes
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?
62571	Aortic arch branch vessel endovascular stent-graft, drug-coated	A non-bioabsorbable tubular device intended for implantation within the left subclavian artery, in connection to a parent endovascular stent-graft (not included) implanted in the aortic arch, to allow unrestricted blood flow. It includes an animal-derived heparin surface to prevent thrombosis; it is not intended to be implanted without the parent stent-graft. It is typically made of a metal alloy that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable implantation devices 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: 14 French
Length: 6 Centimeter
Lumen/Inner Diameter: 12 Millimeter
Lumen/Inner Diameter: 15 Millimeter

Device Record Status

Public Device Record Key: ecd6551b-35d5-4f36-8a45-00bf567b44c3
Public Version Date: December 11, 2024
Public Version Number: 4
DI Record Publish Date: June 27, 2022