Catalog Number

935

Brand Name

PIP

Version/Model Number

935

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 30, 2025

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

-

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

41ee9600-fb7d-492a-b321-f9a8b98a1131

Public Version Date

April 11, 2022

Public Version Number

2

DI Record Publish Date

December 30, 2019

Package DI Number

10732671109351

Quantity per Package

1

Contains DI Package

00732671009357

Package Discontinue Date

December 30, 2025

Package Status

In Commercial Distribution

Package Type

Chipboard Box