Catalog Number

-

Brand Name

Unistik 2 Safety Lancets - Super 21G

Version/Model Number

AT 0752

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

2f4e9288-a800-43cd-8a63-b1b980655ab9

Public Version Date

April 24, 2020

Public Version Number

1

DI Record Publish Date

April 16, 2020

Package DI Number

00384700752033

Quantity per Package

40

Contains DI Package

00384700752019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case