Catalog Number

LS3112

Brand Name

Ligasure

Version/Model Number

LS3112

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2020

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

37c5faed-35cb-4d33-8c57-9ad170a54e33

Public Version Date

August 09, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884524002511

Quantity per Package

12

Contains DI Package

10884524002514

Package Discontinue Date

February 21, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE