Catalog Number

-

Brand Name

LigaSure

Version/Model Number

LS1520

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K031011,K031011

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

401905b4-85df-413a-9c2a-5f2c7a812cca

Public Version Date

April 05, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

40884524002188

Quantity per Package

6

Contains DI Package

10884524002187

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE