Catalog Number

1852

Brand Name

Sonigel Ultrasound Gel Couplants

Version/Model Number

1852

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

K012522

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

a32f1c3b-60cd-47d4-94aa-6ecdc8b5e452

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

-