Catalog Number

-

Brand Name

Ultrasonic Generator

Version/Model Number

USG-400

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

K172691

Product Code

KNS

Product Code Name

Unit, electrosurgical, endoscopic (with or without accessories)

Public Device Record Key

a65e0f7c-3390-404c-8cf2-52386fa61082

Public Version Date

September 24, 2018

Public Version Number

4

DI Record Publish Date

November 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-