Catalog Number

-

Brand Name

TRUEplus

Version/Model Number

TRUEplus SINGLE-USE INSULIN syringes 31 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,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017,K993017

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

42af87eb-286f-4bd4-b81f-17f05ede5805

Public Version Date

April 09, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

00021292005030

Quantity per Package

10

Contains DI Package

00021292005863

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box