Catalog Number

-

Brand Name

One-Step Safety Lancet

Version/Model Number

OS140

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)

-

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

d94ad409-ecc9-42fd-bb04-72824c266197

Public Version Date

November 15, 2021

Public Version Number

4

DI Record Publish Date

January 02, 2017

Package DI Number

58886354702398

Quantity per Package

25

Contains DI Package

38886354702394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case