Catalog Number

-

Brand Name

Diabetic Outlet - Unifine Pentips Plus

Version/Model Number

AN 3850DO

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

1702bd32-f147-498a-aff7-30f8f342cfdd

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

February 26, 2021

Package DI Number

00761059851844

Quantity per Package

6

Contains DI Package

00761059850847

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve