Catalog Number

06-5V-TR13

Brand Name

Omnia Medical VBR

Version/Model Number

06-5V-TR13

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

-

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

62c266c7-ff34-419d-b891-fb6ece3f2fbb

Public Version Date

April 07, 2020

Public Version Number

1

DI Record Publish Date

March 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-