Catalog Number

4617100V-02

Brand Name

Omnifix™

Version/Model Number

4617100V-02

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"

Yes

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

FMF

Product Code Name

Syringe, piston

Public Device Record Key

cd8f815e-f7ba-4247-b4d7-894bbe903bbd

Public Version Date

May 18, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

04046963452230

Quantity per Package

12

Contains DI Package

04046963452223

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton