Catalog Number

012033

Brand Name

AutoSonix

Version/Model Number

012033

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 03, 2020

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)

Yes

Over the Counter (OTC)

-

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

fe65563a-89c3-4fc1-bbe5-b39a483a4528

Public Version Date

August 09, 2021

Public Version Number

3

DI Record Publish Date

August 18, 2018

Package DI Number

20884521058306

Quantity per Package

3

Contains DI Package

10884521058309

Package Discontinue Date

September 03, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE