Catalog Number

-

Brand Name

Venus Legacy CX - LB2 applicator (new design)

Version/Model Number

AS100063

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K143554,K191528,K143554,K191528

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

3d43b129-efd9-4665-8cef-35f7dcdcd575

Public Version Date

June 16, 2020

Public Version Number

2

DI Record Publish Date

November 18, 2018

Package DI Number

07290016541137

Quantity per Package

1

Contains DI Package

07290016540765

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-