Catalog Number

-

Brand Name

Unifine Pentips Plus

Version/Model Number

AN 2829

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

c1f416ff-558b-4838-88f1-d4515fa5df88

Public Version Date

September 16, 2021

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

00384702829030

Quantity per Package

24

Contains DI Package

00384702829023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case