Catalog Number

4934907

Brand Name

LEADER

Version/Model Number

4934907

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

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

K062682,K062682

Product Code

NUC

Product Code Name

Lubricant, personal

Public Device Record Key

b9dfb847-3c9b-4170-9608-6b1090c0b3f2

Public Version Date

July 02, 2021

Public Version Number

4

DI Record Publish Date

July 30, 2019

Package DI Number

50096295125325

Quantity per Package

24

Contains DI Package

00096295125320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE