Catalog Number

-

Brand Name

Logi - Laparoscopic Instrument System

Version/Model Number

120-7001

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

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

K063485,K063485

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

bfc4b24e-bf0d-4254-8dc4-734c5e415c99

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

05051986008028

Quantity per Package

10

Contains DI Package

05051986000398

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box