Catalog Number

S5002A32-100

Brand Name

TRUEplus

Version/Model Number

TRUEplus Pen Needles 32 GAUGE x 5/32"

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"

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

1db66678-e18c-4c32-bff2-edbcb75e062a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

50096295129132

Quantity per Package

30

Contains DI Package

00096295129137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case