Catalog Number

S6007A32-50

Brand Name

TRUEplus

Version/Model Number

TRUEplus Pen Needles - 5Bevel

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

38489173-279a-4a9b-8c6e-0aa4d041d7b6

Public Version Date

April 07, 2022

Public Version Number

2

DI Record Publish Date

March 17, 2022

Package DI Number

10050428647551

Quantity per Package

60

Contains DI Package

00050428647554

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE