Catalog Number

-

Brand Name

JO H2O Gel - Original - Lubricant 4 floz / 120 mL

Version/Model Number

40661

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

K192203,K192203

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

82affef7-1d1b-4a01-9414-2d87e574fc57

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

10796494000851

Quantity per Package

12

Contains DI Package

00796494000854

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-