Catalog Number

S6H01C31-100

Brand Name

TRUEplus

Version/Model Number

TRUEplus 5 bevel Pen Needle 31G/6mm - 100ct box

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171144,K171144,K171144

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

7abe1995-afde-49d2-b752-86f855a1ad41

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 12, 2018

Package DI Number

10021292010789

Quantity per Package

30

Contains DI Package

00021292010782

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case