Catalog Number

-

Brand Name

Ligasure

Version/Model Number

LS3092

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

K981916,K981916

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

eeddc269-1c65-4b6f-8675-fb2055637d42

Public Version Date

April 05, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884524002153

Quantity per Package

12

Contains DI Package

10884524002156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE