Catalog Number

-

Brand Name

RepHresh™ Vaginal Gel Personal Lubricant

Version/Model Number

00022600987628

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

K021737

Product Code

NUC

Product Code Name

Lubricant, personal

Public Device Record Key

1e44a9d0-f30f-4898-9c93-07ef9750c7cb

Public Version Date

December 31, 2021

Public Version Number

7

DI Record Publish Date

May 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-