Catalog Number

5684600

Brand Name

LEADER

Version/Model Number

5684600

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

-

Product Code

KMJ

Product Code Name

Lubricant, patient

Public Device Record Key

a2105cb9-d996-4619-9d2e-3c1c2573bae3

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

May 17, 2021

Package DI Number

50096295140540

Quantity per Package

50

Contains DI Package

00096295140545

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE