AccessGUDID - DEVICE: GORE VIABAHN Endoprosthesis (00733132614622)

GUDID

Device Identifier (DI) Information

Brand Name: GORE VIABAHN Endoprosthesis
Version or Model: VBC081502
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VBC081502
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132614622
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 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:	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?
43526	Peripheral artery endovascular stent-graft, non-medicated	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is a metallic mesh-like structure with a synthetic polymer tube (endovascular graft); it does not include pharmaceuticals.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
NIP	Stent, Superficial Femoral Artery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P040037	002
P130006	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: 15 Centimeter
Lumen/Inner Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: 1b6618a5-e4f9-44c2-949d-25ee073f5838
Public Version Date: December 11, 2024
Public Version Number: 11
DI Record Publish Date: March 04, 2017