Catalog Number

-

Brand Name

ZevRx STERILE INSULIN SYRINGE 5/16” 1/2CC 30G

Version/Model Number

1

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

551d6f1a-acc6-41c0-8312-f8046668811e

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 2022

Package DI Number

10850632007826

Quantity per Package

20

Contains DI Package

00850632007829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case