Catalog Number

S6H01D31-100V

Brand Name

TRUEplus

Version/Model Number

TRUEplus 5-bevel Pen Needle 31G/8mm - 100ct box

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 19, 2021

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

f3aeaf4b-dcbf-4a24-93c8-0c4bc1d2305f

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

September 22, 2021

Package DI Number

10021292014770

Quantity per Package

30

Contains DI Package

00021292014773

Package Discontinue Date

November 19, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE