Catalog Number

990430

Brand Name

Prodigy Insulin Syringes

Version/Model Number

990430

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

d6f48868-0cdf-422e-821e-64e982d5f965

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

00384843904306

Quantity per Package

5

Contains DI Package

00384849904300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Carton