Catalog Number

ACCY-008

Brand Name

Sonata® RFA Handpiece Cable, Reusable

Version/Model Number

ACCY-008

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

K211535,K211535

Product Code

KNF

Product Code Name

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Public Device Record Key

4d9f1733-3471-4629-b2b3-5ca734b8b431

Public Version Date

July 15, 2021

Public Version Number

1

DI Record Publish Date

July 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-