Catalog Number

328519

Brand Name

Relion Insulin Syringe, 1ml 6mm

Version/Model Number

328519

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

217da049-1d63-497c-878c-201334e3641d

Public Version Date

July 13, 2018

Public Version Number

1

DI Record Publish Date

June 12, 2018

Package DI Number

50382903285193

Quantity per Package

500

Contains DI Package

00681131138345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case