Catalog Number

90-3014

Brand Name

Mariner

Version/Model Number

90-3014

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 12, 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

-

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

fe9a9c4b-320f-4c07-b4e7-b66711c96999

Public Version Date

June 14, 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

-