AccessGUDID - DEVICE: VICI VENOUS STENT ® SYSTEM (00852725008096)

GUDID

Device Identifier (DI) Information

Brand Name: VICI VENOUS STENT ® SYSTEM
Version or Model: H74912060100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H74912060100
Company Name: Veniti Inc

Primary DI Number: 00852725008096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079757164 *Terms of Use

Device Description: N/A

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?
58057	Bare-metal peripheral venous stent	A non-bioabsorbable, tubular device made of metal intended to be implanted in a peripheral (typically the iliac and/or femoral) vein to maintain patency in patients with constrained venous outflow; it is not intended for coronary or intracranial venous stenting. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. It is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QAN	Stent, iliac vein

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180013	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: 100 Centimeter
Stent Length: 60 Millimeter
Stent Diameter: 12 Millimeter

Device Record Status

Public Device Record Key: 76c4ea80-120e-44f9-916a-8e30c8411d8f
Public Version Date: November 25, 2024
Public Version Number: 3
DI Record Publish Date: May 09, 2019