Catalog Number

-

Brand Name

VenaCure EVLT

Version/Model Number

EVLTPVAKUS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

ae4c24ff-10d2-4b96-a3dc-3275264594dc

Public Version Date

January 01, 2019

Public Version Number

2

DI Record Publish Date

October 17, 2018

Package DI Number

H787EVLTPVAKUS5

Quantity per Package

5

Contains DI Package

H787EVLTPVAKUS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX