Catalog Number

-

Brand Name

TRUEplus

Version/Model Number

TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 1.0cc insulin

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"

-

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

K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

6ca2f8f9-a9fc-4d63-9868-259d3abb46cf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

50096295125394

Quantity per Package

8

Contains DI Package

00096295125399

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case