Catalog Number

-

Brand Name

Sterilance Flex3 Depth Adjustable Safety Lancet

Version/Model Number

05-1523A

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

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Public Device Record Key

94036459-4e30-4f49-9e07-288d2fa34802

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Package DI Number

36945630111892

Quantity per Package

1000

Contains DI Package

16945630111898

Package Discontinue Date

March 10, 2022

Package Status

Not in Commercial Distribution

Package Type

-