Catalog Number

8881541604

Brand Name

Monoject

Version/Model Number

8881541604

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K980062,K980062,K980062

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

fb2904fa-6c93-4066-9bdc-00a70b594e4b

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

30884521124978

Quantity per Package

400

Contains DI Package

10884521124974

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE