Catalog Number

-

Brand Name

LigaSure

Version/Model Number

LF2019

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"

Yes

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

K173281,K173281

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

4f6a6c67-a6bc-46e8-bb32-8d2e93c5d38a

Public Version Date

April 05, 2022

Public Version Number

3

DI Record Publish Date

March 21, 2018

Package DI Number

20884521741093

Quantity per Package

6

Contains DI Package

10884521741096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE