Catalog Number

328520

Brand Name

Relion Insulin Syringe, 1/2ml

Version/Model Number

328520

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

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

8ce8a26b-53c2-4a36-a4ab-62774f4e9ba7

Public Version Date

July 13, 2018

Public Version Number

1

DI Record Publish Date

June 12, 2018

Package DI Number

50382903285209

Quantity per Package

500

Contains DI Package

00681131138369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case