AccessGUDID - DEVICE: GORE VIABAHN VBX Balloon Expandable Endo (00733132637294)

GUDID

Device Identifier (DI) Information

Brand Name: GORE VIABAHN VBX Balloon Expandable Endo
Version or Model: BXA075902A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BXA075902A
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132637294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: VIABAHN BX BALLOON EXP ENDO 7mmX59mm 7Fr 135cmCath 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?
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	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
Device Size Text, specify: Catheter Working Length: 135 CM
Catheter Gauge: 7 French
Outer Diameter: 7 Millimeter
Length: 59 Millimeter

Device Record Status

Public Device Record Key: 0f795ddd-2699-410f-9796-416c23af3bfa
Public Version Date: December 11, 2024
Public Version Number: 11
DI Record Publish Date: January 31, 2017