Catalog Number

609S

Brand Name

ADVOCATE Syringes for U-100 insulin 31G 1CC 5/16" Needle

Version/Model Number

609

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)

-

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

9182d5a9-45a3-4b34-a871-8c7ea5944fee

Public Version Date

February 07, 2022

Public Version Number

7

DI Record Publish Date

August 20, 2016

Package DI Number

00894046001684

Quantity per Package

10

Contains DI Package

00894046001837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

610