Catalog Number

613S

Brand Name

Advocate Syringes for U-100 Insulin 31G .3CC 5/16" Needle

Version/Model Number

613

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

5ee9a18d-8c49-45a9-b312-ac666a1c68f7

Public Version Date

November 01, 2022

Public Version Number

7

DI Record Publish Date

August 20, 2016

Package DI Number

00894046001721

Quantity per Package

10

Contains DI Package

00894046001820

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

614