Catalog Number

DE-001

Brand Name

Sonata® Dispersive Electrode

Version/Model Number

DE-001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KNF

Product Code Name

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Public Device Record Key

6e2e1fe0-3d7a-47f4-be55-5c43da836bcb

Public Version Date

July 15, 2021

Public Version Number

1

DI Record Publish Date

July 07, 2021

Package DI Number

30817929020368

Quantity per Package

10

Contains DI Package

10817929020364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10-Pack Dispenser