Catalog Number

VEN-3-60

Brand Name

Endovenous Radiofrequency Ablation (RFA) Catheter

Version/Model Number

VEN-3-60

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 09, 2023

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

f5fde442-f9ef-4482-a19e-2d8e1dacfed8

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

June 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-