Catalog Number

FG00001

Brand Name

Sofwave

Version/Model Number

FG00001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191421,K211483

Product Code

OHV

Product Code Name

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Public Device Record Key

750d9437-527d-4f1f-8a7a-90ee00f9a54c

Public Version Date

April 07, 2022

Public Version Number

4

DI Record Publish Date

November 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-