Catalog Number

7580

Brand Name

PremierPro Lancet

Version/Model Number

7580

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172763,K172763,K172763

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

b02cbba1-2c71-4095-a517-58aa4e537aba

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

April 08, 2021

Package DI Number

00811220033408

Quantity per Package

200

Contains DI Package

00811220033378

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box