Catalog Number

-

Brand Name

WALLACH® Summit Doppler™ Ultrasound Gel 250 grams

Version/Model Number

G155

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

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

-

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

d376ad39-98c9-4cfe-b8cc-573c7742e95f

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-