Catalog Number

5075122

Brand Name

LEADER

Version/Model Number

5075122

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

K152339,K152339,K152339,K152339

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

e78c7ca5-b2bf-462f-b3d3-8421e35c9366

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

February 11, 2020

Package DI Number

50096295126919

Quantity per Package

4

Contains DI Package

30096295126915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE