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

-

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

5dff9603-80d6-489b-bf43-6b5db1c92b61

Public Version Date

November 03, 2021

Public Version Number

1

DI Record Publish Date

October 26, 2021

Package DI Number

10860036000569

Quantity per Package

10

Contains DI Package

00860036000562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case