Catalog Number

-

Brand Name

Sonicision

Version/Model Number

SCBA

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"

Yes

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

K180149

Product Code

LFL

Product Code Name

Instrument, ultrasonic surgical

Public Device Record Key

f2096bf8-1bb6-47f7-b4ee-469f2a8f4e78

Public Version Date

April 29, 2022

Public Version Number

8

DI Record Publish Date

August 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-