Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-8919

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)

Yes

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

46e6c4b6-bdef-4361-a2dc-ae5354879ec9

Public Version Date

May 02, 2019

Public Version Number

1

DI Record Publish Date

April 24, 2019

Package DI Number

00612479225053

Quantity per Package

6

Contains DI Package

00612479225046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case