Catalog Number

-

Brand Name

Sterilance LDE3

Version/Model Number

02-1903

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

1c6b877b-d838-4fbd-93d1-6b37d475d8b0

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

Package DI Number

16945630112895

Quantity per Package

1

Contains DI Package

06945630112898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-