Catalog Number

-

Brand Name

REVAREE

Version/Model Number

VAGINAL SUPPOSITORIES 2 g

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

K153372,K153372

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

d6b72e5e-ba20-4597-9a15-a7cf302f64b7

Public Version Date

August 20, 2020

Public Version Number

4

DI Record Publish Date

February 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-