Catalog Number

205ST

Brand Name

HR Lubricating Jelly

Version/Model Number

205ST

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"

Yes

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

-

Product Code

KMJ

Product Code Name

Lubricant, patient

Public Device Record Key

138a346b-da66-41ec-84a2-5e0a48a40289

Public Version Date

September 27, 2018

Public Version Number

1

DI Record Publish Date

August 27, 2018

Package DI Number

20851809002504

Quantity per Package

4

Contains DI Package

10851809002507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case