Catalog Number

8881609004

Brand Name

Monoject

Version/Model Number

8881609004

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

b123afac-4089-4e7d-9181-8112d6abbe4d

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884527022649

Quantity per Package

300

Contains DI Package

00884527022642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE