Catalog Number

MC1-200020

Brand Name

Mariner Cortical

Version/Model Number

MC1-200020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 21, 2021

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

-

Product Code

NKB

Product Code Name

Thoracolumbosacral pedicle screw system

Public Device Record Key

d0fad9b2-7bef-49f2-a5a7-36c7c133e61e

Public Version Date

July 21, 2021

Public Version Number

2

DI Record Publish Date

January 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-