Catalog Number

1864

Brand Name

Sonigel Lotion with Aloe Vera

Version/Model Number

1864

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K013212

Product Code

MUI

Product Code Name

Media,coupling,ultrasound

Public Device Record Key

060daad4-e5e8-4698-b4b0-0316517e803e

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

January 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-