Catalog Number

S7H01RN28-100

Brand Name

TRUEplus

Version/Model Number

TRUEplus Safety 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

d7f98c7a-8128-4a7f-9e84-94e1c8f9aec5

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 23, 2020

Package DI Number

10021292010536

Quantity per Package

12

Contains DI Package

00021292010539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE