Catalog Number

SW-002

Brand Name

Sonata System Software

Version/Model Number

SW-002

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

-

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

K193516

Product Code

KNF

Product Code Name

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Public Device Record Key

dd340bef-aeaa-43c4-b60f-076bd1393ac6

Public Version Date

October 15, 2020

Public Version Number

1

DI Record Publish Date

October 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-