Catalog Number

MC1-200045

Brand Name

Mariner MCT

Version/Model Number

MC1-200045

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

K173882

Product Code

NKB

Product Code Name

Thoracolumbosacral pedicle screw system

Public Device Record Key

1b5c5dfa-5aed-4c03-a5b3-5ed1a9ed3fe9

Public Version Date

April 18, 2019

Public Version Number

1

DI Record Publish Date

April 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-