Catalog Number

-

Brand Name

Disposable Electrode Series

Version/Model Number

LE-01-104

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091672,K091672

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

1213ea8c-f46d-4e77-a432-d88fdb189d4a

Public Version Date

July 09, 2019

Public Version Number

1

DI Record Publish Date

July 01, 2019

Package DI Number

16924274956997

Quantity per Package

5

Contains DI Package

06924274956990

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-