Catalog Number

MM2-000402

Brand Name

Mariner MIS

Version/Model Number

MM2-000402

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

-

Product Code

HWD

Product Code Name

STARTER, BONE SCREW

Public Device Record Key

0a590555-e1a2-4db5-9f65-14f450e7f4cc

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-