AccessGUDID - DEVICE: GORE VIABAHN VBX Balloon Expandable Endo (00733132658640)

GUDID

Device Identifier (DI) Information

Brand Name: GORE VIABAHN VBX Balloon Expandable Endo
Version or Model: BXB073902A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BXB073902A
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132658640
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: BX2 HEP REDUCED PROFILE BX2 7MMX39MM 6Fr 135CM Cath

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?
66619	Peripheral artery endovascular stent-graft, drug-coated	A non-bioabsorbable tubular implantable device intended to maintain patency and improve luminal diameter of a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries), and that includes a heparin coating intended to prevent thrombotic vessel re-narrowing. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal arteries), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is comprised of a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PRL	Iliac covered stent, arterial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160021	039

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 3.9 Centimeter
Lumen/Inner Diameter: 7 Millimeter
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: 5704d071-91c5-4906-b6b7-06ba15bfde7c
Public Version Date: December 11, 2024
Public Version Number: 4
DI Record Publish Date: December 11, 2023