Catalog Number

LE-28-108

Brand Name

NA

Version/Model Number

Loop 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

Product Code

HGI

Product Code Name

Electrocautery, Gynecologic (And Accessories)

Public Device Record Key

d1713aca-e3ee-4fe4-8431-520bcaeef994

Public Version Date

May 27, 2019

Public Version Number

4

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-