Catalog Number

-

Brand Name

Premier Value 1st Tier Unifine Pentips Plus

Version/Model Number

AN 0860CDCSB2

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)

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

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

7f98dff9-714c-4da7-a584-0f1371ba7265

Public Version Date

August 05, 2021

Public Version Number

2

DI Record Publish Date

January 29, 2021

Package DI Number

00761059862284

Quantity per Package

200

Contains DI Package

00761059860280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case