Catalog Number

185189

Brand Name

NovoFine® 32G Tip

Version/Model Number

185189

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090111,K173479,K090111,K173479,K090111,K173479

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

229914a2-4937-4dd3-984f-aa722fb01fb0

Public Version Date

April 03, 2019

Public Version Number

5

DI Record Publish Date

September 17, 2016

Package DI Number

30301691851898

Quantity per Package

60

Contains DI Package

00301691851897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-