Catalog Number

-

Brand Name

Replens™ Silky Smooth Personal Lubricant

Version/Model Number

00022600001089

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

K110690

Product Code

NUC

Product Code Name

Lubricant, personal

Public Device Record Key

052ca7d0-0a78-4fba-9a08-35cfdb8b7749

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

October 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-