Catalog Number

-

Brand Name

SteriLance Lancing Device Model LDE 4-AST

Version/Model Number

02-2201

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"

-

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

bb138257-0130-4399-8906-ab30a5054872

Public Version Date

June 22, 2022

Public Version Number

1

DI Record Publish Date

June 14, 2022

Package DI Number

36945630112707

Quantity per Package

10

Contains DI Package

16945630112703

Package Discontinue Date

June 14, 2022

Package Status

Not in Commercial Distribution

Package Type

-