Catalog Number

-

Brand Name

Unistik 3

Version/Model Number

AT1012

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

bac073d7-35f2-4dcb-b82d-a6c11610e1f0

Public Version Date

June 17, 2021

Public Version Number

2

DI Record Publish Date

September 12, 2019

Package DI Number

00384701012037

Quantity per Package

40

Contains DI Package

00384701012013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case