Catalog Number

-

Brand Name

Good Sense Pen Needles

Version/Model Number

700014725

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

8a8a3a02-f921-4038-8f59-de631e6bd17e

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

March 01, 2019

Package DI Number

50370030125345

Quantity per Package

20

Contains DI Package

00370030125340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper