Catalog Number

206

Brand Name

HR Lubricating Jelly

Version/Model Number

206

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

34d3da14-574e-4d22-80d4-06a981f32217

Public Version Date

July 31, 2019

Public Version Number

1

DI Record Publish Date

July 23, 2019

Package DI Number

50851809002062

Quantity per Package

400

Contains DI Package

00851809002067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case