Catalog Number

805

Brand Name

ReadyLance

Version/Model Number

805

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 01, 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)

-

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

01b780f8-ef6e-4989-8130-2f55e260c6f6

Public Version Date

August 28, 2020

Public Version Number

2

DI Record Publish Date

June 01, 2020

Package DI Number

30732671308055

Quantity per Package

4

Contains DI Package

20732671208051

Package Discontinue Date

June 01, 2025

Package Status

In Commercial Distribution

Package Type

Corrugate Carton