Catalog Number

36-1500-15

Brand Name

Pharmaceutical Innovations

Version/Model Number

Gentle Gel Lubricating 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

MMS

Product Code Name

Lubricant, Vaginal, Patient

Public Device Record Key

02835da5-7e63-40d7-a845-8ea257cb6f6d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2016

Package DI Number

10300361500155

Quantity per Package

12

Contains DI Package

00300361500158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-