Catalog Number

8881216033

Brand Name

Monoject

Version/Model Number

8881216033

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)

Yes

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

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

e5b0b32e-a205-460d-b113-0082654f4491

Public Version Date

April 07, 2021

Public Version Number

9

DI Record Publish Date

September 24, 2016

Package DI Number

20884521012780

Quantity per Package

1000

Contains DI Package

10884521012783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE