Catalog Number

-

Brand Name

Unifine Safe Control

Version/Model Number

AN 0935SB2

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

K173881,K173881,K173881

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

e36de00a-f6f3-4c6a-bbfd-8f63c3845c3d

Public Version Date

August 05, 2021

Public Version Number

2

DI Record Publish Date

October 02, 2020

Package DI Number

00384700935238

Quantity per Package

500

Contains DI Package

00384700935214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case