Catalog Number

-

Brand Name

Sonicision

Version/Model Number

SCT12

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

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

K101797,K101797

Product Code

LFL

Product Code Name

Instrument, ultrasonic surgical

Public Device Record Key

78a3188c-0df9-4c1f-87b3-fd69c61f1b82

Public Version Date

August 29, 2022

Public Version Number

4

DI Record Publish Date

August 10, 2018

Package DI Number

20884524002955

Quantity per Package

12

Contains DI Package

10884524002958

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE