Catalog Number

012040

Brand Name

AutoSonix

Version/Model Number

012040

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 02, 2019

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K971861,K971861

Product Code

LFL

Product Code Name

Instrument, ultrasonic surgical

Public Device Record Key

5e2c9046-ca4a-4aed-a3e5-565f6e2e5829

Public Version Date

August 09, 2021

Public Version Number

2

DI Record Publish Date

August 10, 2018

Package DI Number

20884521058344

Quantity per Package

3

Contains DI Package

10884521058347

Package Discontinue Date

October 02, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE