Catalog Number

-

Brand Name

Insulin Pen Needle

Version/Model Number

0.25×5mm

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

4a92aaf3-c872-4894-941d-e9b5eb7da2dc

Public Version Date

January 20, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

06949236200416

Quantity per Package

50

Contains DI Package

06949236200232

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-