Catalog Number

9151117US

Brand Name

Omnican®

Version/Model Number

9151117US

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

546c4f60-64b2-4f88-9bea-d08a234482dc

Public Version Date

October 14, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

04046963456634

Quantity per Package

24

Contains DI Package

04046963456627

Package Discontinue Date

October 20, 2017

Package Status

Not in Commercial Distribution

Package Type

Carton