Catalog Number

200602

Brand Name

BioNourish Vaginal Gel

Version/Model Number

2oz

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

K193448,K193448

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

7bd2d436-5134-4720-afc4-577cbb0c99a4

Public Version Date

April 22, 2022

Public Version Number

1

DI Record Publish Date

April 14, 2022

Package DI Number

30893268000681

Quantity per Package

24

Contains DI Package

00893268000680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case