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,K172691

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

2a2d9493-5752-4a9d-a9d2-a443c24215d2

Public Version Date

September 05, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

14953170306751

Quantity per Package

1

Contains DI Package

04953170306754

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-