Catalog Number

4214409

Brand Name

LEADER

Version/Model Number

4214409

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

FMK

Product Code Name

Lancet, blood

Public Device Record Key

059d3afa-82bf-427b-a78f-8bf0d7c674f7

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

June 28, 2019

Package DI Number

50096295117085

Quantity per Package

20

Contains DI Package

00096295117080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE