Catalog Number

8881401031

Brand Name

Monoject

Version/Model Number

8881401031

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

DZM

Product Code Name

NEEDLE, DENTAL

Public Device Record Key

a79aeb44-0af6-48bc-be63-67df1ab1728a

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 28, 2018

Package DI Number

10884521512078

Quantity per Package

1000

Contains DI Package

10884521002784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE