Catalog Number

8881202082

Brand Name

Monoject

Version/Model Number

8881202082

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

81759d5e-70d0-4aaf-b245-a58b0bb7e7f6

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Package DI Number

10884521072633

Quantity per Package

1000

Contains DI Package

20884521072630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE