Catalog Number

-

Brand Name

VenaCure EVLT

Version/Model Number

EVLT/55-OPS

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

K041957,K041957

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

9afa8901-8a8b-40b1-b05c-bbafc61504ce

Public Version Date

April 01, 2019

Public Version Number

2

DI Record Publish Date

January 11, 2019

Package DI Number

H787EVLT55OPS5

Quantity per Package

5

Contains DI Package

H787EVLT55OPS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box