Catalog Number

-

Brand Name

Good Sense Pen Needles

Version/Model Number

700013864

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

546ec0a9-7592-4338-b846-9727ee239114

Public Version Date

November 20, 2018

Public Version Number

2

DI Record Publish Date

October 12, 2018

Package DI Number

20370030125214

Quantity per Package

12

Contains DI Package

00370030125210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper