Catalog Number

-

Brand Name

VenaCure EVLT

Version/Model Number

11403101

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

K130671

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

63712db7-c078-436f-8502-949f26753228

Public Version Date

February 12, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

H787114031015

Quantity per Package

1

Contains DI Package

H787114031010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX