Catalog Number

500101

Brand Name

RESTORE MOISTURIZING VAGINAL GEL

Version/Model Number

5 mL

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162207,K162207

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

d8889f2e-7368-4c6a-b935-a035023c229c

Public Version Date

April 20, 2022

Public Version Number

1

DI Record Publish Date

April 12, 2022

Package DI Number

30893268000711

Quantity per Package

900

Contains DI Package

00893268000710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case