AccessGUDID - DEVICE: TIGRIS Vascular Stent (00733132636310)

GUDID

Device Identifier (DI) Information

Brand Name: TIGRIS Vascular Stent
Version or Model: PHA070302A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PHA070302A
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132636310
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: No description.

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?
47932	Peripheral artery stent, bare-metal	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIP	Stent, Superficial Femoral Artery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160004	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
Length: 30 Millimeter
Lumen/Inner Diameter: 7 Millimeter
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: e5fe2edb-d304-4a3a-b47b-20e566ff6953
Public Version Date: December 11, 2024
Public Version Number: 11
DI Record Publish Date: August 03, 2016