AccessGUDID - DEVICE: Duo Extend Venous Stent System (00810010693280)

GUDID

Device Identifier (DI) Information

Brand Name: Duo Extend Venous Stent System
Version or Model: N1201212009120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N1201212009120
Company Name: Vesper Medical, Inc.

Primary DI Number: 00810010693280
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080441571 *Terms of Use

Device Description: Duo Extend Venous Stent System, 12mm x 120mm Stent, 9F x 120cm Delivery System

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 [?]
P230021	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
No Device Sizes

Device Record Status

Public Device Record Key: a3953867-8e14-425e-ac6c-1caba323eed2
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: May 01, 2024