Catalog Number

-

Brand Name

Sterilance Press Pressure Activated Safety Lancet

Version/Model Number

05-052618

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)

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

a7464f08-f509-4fa7-b0ad-a5cc199948f0

Public Version Date

November 25, 2020

Public Version Number

1

DI Record Publish Date

November 17, 2020

Package DI Number

36945630108823

Quantity per Package

2500

Contains DI Package

16945630108829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE