Catalog Number

LE-13-003

Brand Name

NA

Version/Model Number

Ball Electrode

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"

Yes

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

K022593,K022593,K022593

Product Code

HGI

Product Code Name

Electrocautery, Gynecologic (And Accessories)

Public Device Record Key

9c8e83d5-5575-4484-a129-5a1b10afcf9a

Public Version Date

July 03, 2020

Public Version Number

4

DI Record Publish Date

October 10, 2016

Package DI Number

10852073002392

Quantity per Package

5

Contains DI Package

00852073002395

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box