Catalog Number

24-082316

Brand Name

Prodigy Pressure Activated Safety Lancets

Version/Model Number

24-082316

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

5cc1eec2-4d47-49ee-9e79-4f22f4f14fa3

Public Version Date

September 21, 2018

Public Version Number

1

DI Record Publish Date

August 21, 2018

Package DI Number

30384840823168

Quantity per Package

10

Contains DI Package

00384840823167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Box