Catalog Number

4938494

Brand Name

LEADER

Version/Model Number

4938494

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152339,K152339,K152339,K152339

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

207e6fc1-45ac-48e9-8ec0-e686e5ed88a3

Public Version Date

May 10, 2022

Public Version Number

4

DI Record Publish Date

July 07, 2017

Package DI Number

50096295125592

Quantity per Package

24

Contains DI Package

30096295125598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE