Catalog Number

8881501962

Brand Name

Monoject

Version/Model Number

8881501962

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2025

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)

Yes

Over the Counter (OTC)

-

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

ca6f2a26-d633-4faa-96f3-bd668aa22ce9

Public Version Date

May 10, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884521014111

Quantity per Package

1000

Contains DI Package

10884521014114

Package Discontinue Date

December 31, 2025

Package Status

In Commercial Distribution

Package Type

CASE