Catalog Number

-

Brand Name

TRUEplus

Version/Model Number

TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 0.3cc 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

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

787efa0b-5faa-40c9-9b70-996434d3602a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10087701426091

Quantity per Package

8

Contains DI Package

00087701426094

Package Discontinue Date

October 12, 2017

Package Status

Not in Commercial Distribution

Package Type

Case