Catalog Number

S5209D31-100TC

Brand Name

TRUEplus

Version/Model Number

TRUEplus 3-Bevel Pen Needles 31G/8mm Tae Cha

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180720,K180720,K180720

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

c4310845-4e7c-499a-9bd2-bbc8a50030a1

Public Version Date

April 19, 2019

Public Version Number

1

DI Record Publish Date

April 11, 2019

Package DI Number

10036800234502

Quantity per Package

30

Contains DI Package

00036800234505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case