Catalog Number

9161708VUS

Brand Name

Omnifix™

Version/Model Number

9161708VUS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 20, 2017

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)

-

Over the Counter (OTC)

Yes

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

345e03fc-821c-4923-9856-be851d2cdf9b

Public Version Date

March 11, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

04046963452537

Quantity per Package

18

Contains DI Package

04046963452520

Package Discontinue Date

October 20, 2017

Package Status

Not in Commercial Distribution

Package Type

Carton