Catalog Number

S5002D31-100

Brand Name

TRUEplus

Version/Model Number

TRUEplus Pen Needles 31 GAUGE x 5/16"

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2020

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"

Yes

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

K143437,K143437,K143437

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

f57c104e-49d9-4019-9c23-caa11304ecf7

Public Version Date

April 09, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

50096295129125

Quantity per Package

30

Contains DI Package

00096295129120

Package Discontinue Date

March 11, 2020

Package Status

Not in Commercial Distribution

Package Type

Case