Catalog Number

-

Brand Name

Mixject (TM) with spray head

Version/Model Number

9070113

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

K122023,K122023

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

259f8e07-5b23-4977-ac15-cf68db7d2e90

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

May 01, 2016

Package DI Number

27290108240935

Quantity per Package

300

Contains DI Package

07290108240931

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-