Catalog Number

S3089-01

Brand Name

TRUEdraw

Version/Model Number

HealthMart TRUEdraw Lancing Device

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

-

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

7da28937-40a9-431d-b422-36139ebb1f3a

Public Version Date

December 22, 2020

Public Version Number

1

DI Record Publish Date

December 14, 2020

Package DI Number

10052569138424

Quantity per Package

50

Contains DI Package

00052569138427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case