Catalog Number

-

Brand Name

Pure Comfort Insulin Pen Needles 32G 8mm 50cnt

Version/Model Number

INSP32-8

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

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

70ab8c2a-cf70-4183-ab21-15efd943c8a9

Public Version Date

March 25, 2021

Public Version Number

2

DI Record Publish Date

February 26, 2020

Package DI Number

10860003125547

Quantity per Package

50

Contains DI Package

00860003125540

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton