Catalog Number

-

Brand Name

1st Tier Unifine Pentips Plus Original

Version/Model Number

AN 3829FT

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

3fcb92b8-d642-4e15-bb39-0a9eb005c228

Public Version Date

March 17, 2022

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

00761059820369

Quantity per Package

6

Contains DI Package

00761059829362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve