Catalog Number

-

Brand Name

Disposable Electrode Series

Version/Model Number

SG005-NNS

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

95526d81-55ee-4213-9817-848bebd2d167

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 14, 2020

Package DI Number

16924274957185

Quantity per Package

20

Contains DI Package

06924274957188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-