Catalog Number

-

Brand Name

Unifine Pentips Plus

Version/Model Number

AN 3860

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152339,K152339,K152339,K152339

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

39c5a3b6-6897-4fca-aeb9-c9ba7543eaaa

Public Version Date

March 17, 2022

Public Version Number

3

DI Record Publish Date

October 03, 2018

Package DI Number

00384703860032

Quantity per Package

24

Contains DI Package

00384703860025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case