Catalog Number

8881204005

Brand Name

Monoject

Version/Model Number

8881204005

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Public Device Record Key

4facf85a-f002-4ca3-bbb0-316edde76e7a

Public Version Date

August 09, 2019

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

20884521014852

Quantity per Package

1000

Contains DI Package

10884521014855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE