AccessGUDID - DEVICE: Venovo® (00801741103797)

GUDID

Device Identifier (DI) Information

Brand Name: Venovo®
Version or Model: VENUL18100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VENUL18100
Company Name: Angiomed GmbH & Co. Medizintechnik KG

Primary DI Number: 00801741103797
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320047483 *Terms of Use

Device Description: Venovo® Venous Stent System 18 mm x 100 mm (120 cm delivery catheter)

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":	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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: Implant Length, 100 Millimeter
Device Size Text, specify: Implant Diameter, 18 Millimeter
Device Size Text, specify: Catheter Length, 120 Centimeter

Device Record Status

Public Device Record Key: e2d2abe4-0591-4934-9daf-de51adf568e6
Public Version Date: November 25, 2024
Public Version Number: 3
DI Record Publish Date: March 18, 2019