Catalog Number

-

Brand Name

Venclose System EVSRF Catheter

Version/Model Number

VC-10A2.5-6F-60

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K160754,K160754,K160754

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

231737ba-57f0-4153-9f1e-ac10f40ff95c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 01, 2016

Package DI Number

00858254006213

Quantity per Package

10

Contains DI Package

00858254006008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box