Catalog Number

816

Brand Name

ReadyLance

Version/Model Number

816

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 27, 2025

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)

Yes

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

9f5c55f1-ad98-4b86-92aa-656f47a81114

Public Version Date

April 11, 2022

Public Version Number

2

DI Record Publish Date

August 27, 2020

Package DI Number

00732671008169

Quantity per Package

10

Contains DI Package

10732671108163

Package Discontinue Date

August 27, 2025

Package Status

In Commercial Distribution

Package Type

Poly Bag