Catalog Number

-

Brand Name

Disposable Electrode Series

Version/Model Number

SY-IB-1

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

72811003-b723-4b24-afdd-704a615d58ee

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 2020

Package DI Number

16924274957178

Quantity per Package

10

Contains DI Package

06924274957171

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-