Catalog Number

IDDKRBE4

Brand Name

ID Jelly

Version/Model Number

Jelly 4.4 fl oz Retail

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

K051295,K051295

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

251819c0-f74b-4307-9c33-8eca2de884ec

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

January 19, 2017

Package DI Number

30761236901134

Quantity per Package

12

Contains DI Package

00761236901133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-