Catalog Number

06-0V-1218

Brand Name

Omnia Medical VBR

Version/Model Number

06-0V-1218

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

K172323

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

eef1c610-dfc2-4558-aad9-360d50709684

Public Version Date

September 10, 2019

Public Version Number

4

DI Record Publish Date

February 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-