Catalog Number

-

Brand Name

Logi

Version/Model Number

459-7000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111986,K111986

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

0770682f-16e8-4b08-8973-c1021e7fad21

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

January 04, 2017

Package DI Number

05051986011905

Quantity per Package

10

Contains DI Package

05051986011899

Package Discontinue Date

December 31, 2019

Package Status

Not in Commercial Distribution

Package Type

Inner