Catalog Number

-

Brand Name

SmartMix™ 90° Flanged Nozzle

Version/Model Number

5401-52-000

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

-

Product Code

KIH

Product Code Name

Dispenser, Cement

Public Device Record Key

c2225a20-9460-420e-a4f9-d09e7aa6b63a

Public Version Date

August 31, 2022

Public Version Number

1

DI Record Publish Date

August 23, 2022

Package DI Number

25060238200138

Quantity per Package

10

Contains DI Package

15060238200131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton