Catalog Number

S1007LB28-100

Brand Name

TRUEplus

Version/Model Number

CVS TRUEplus Lancets

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

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Public Device Record Key

3a8030f4-8a3a-495e-923c-bde98c0067d7

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

10050428648824

Quantity per Package

24

Contains DI Package

00050428648827

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE