Catalog Number

FG00002-R

Brand Name

Sofwave Applicator

Version/Model Number

FG00002-R

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

Product Code

OHV

Product Code Name

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Public Device Record Key

315cc7f4-7021-4f4c-a85a-5a820dd8a2dd

Public Version Date

June 04, 2021

Public Version Number

1

DI Record Publish Date

May 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-