Catalog Number

36-1150-04

Brand Name

Pharmaceutical Innovations

Version/Model Number

GAMMA Massage & Ultrasound Gel

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

Yes

Prescription Use (Rx)

-

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

b5d208ab-c9d8-4c2c-adff-2f21987ff701

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

10300361150046

Quantity per Package

1

Contains DI Package

00300361150049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-