Catalog Number

-

Brand Name

Kinray 1st Tier Unifine Pentips Plus

Version/Model Number

AN 3830KI

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

f978cb4a-bc48-4276-ada3-e34ae00db8ca

Public Version Date

August 05, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2020

Package DI Number

00761059831198

Quantity per Package

6

Contains DI Package

00761059830191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve