Catalog Number

-

Brand Name

HEB jelly PERSONAL LUBRICANT

Version/Model Number

7W9261JC1

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

-

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

K180923,K180923

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

4bb03b6f-f435-4905-aa64-841dec6b564e

Public Version Date

December 16, 2021

Public Version Number

1

DI Record Publish Date

December 08, 2021

Package DI Number

10041220823229

Quantity per Package

72

Contains DI Package

00041220823222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper