AccessGUDID - DEVICE: GORE VIATORR TIPS Endoprosthesis (00733132609758)

GUDID

Device Identifier (DI) Information

Brand Name: GORE VIATORR TIPS Endoprosthesis
Version or Model: PTB085275
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PTB085275
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132609758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: VIATORR ENDOPROTHESIS 8MMX5/2CM VIATORR

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?
58043	Endoprosthetic portosystemic shunt	A device intended to be permanently implanted to create or revise a transjugular intrahepatic portosystemic shunt (TIPS), a bypass for blood made between the portal and hepatic veins of the liver delivered to the liver via percutaneous access from the jugular vein, to treat portal hypertension and its complications (e.g., bleeding varices, gastropathy, ascites, and/or hepatic hydrothorax). It is a stent-like tube typically made of metal and polymer materials [e.g., nickel-titanium alloy (Nitinol), expanded polytetrafluoroethylene (ePTFE)] that expand upon implantation. It is implanted using a catheter delivery system and is available in various diameters (e.g., 8 - 12 mm).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIR	Shunt, Portosystemic, Endoprosthesis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P040027	033

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: 5 Centimeter
Outer Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: a31cebce-ae99-4087-ac8c-59477456c520
Public Version Date: August 29, 2023
Public Version Number: 6
DI Record Publish Date: February 13, 2017