Catalog Number

S1054MC33-100

Brand Name

TRUEplus

Version/Model Number

Sunmark TRUEplus Sterile 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

Lancet, Blood

Public Device Record Key

2b3dfcd7-eff9-4bbc-adb8-fab925bc6f0b

Public Version Date

November 04, 2020

Public Version Number

1

DI Record Publish Date

October 27, 2020

Package DI Number

10010939702446

Quantity per Package

24

Contains DI Package

00010939702449

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE