Mariner MCT - Face-cutting Reamer, Tri-flat - SEASPINE ORTHOPEDICS CORPORATION

Duns Number:079840876

Device Description: Face-cutting Reamer, Tri-flat

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More Product Details

Catalog Number

MC2-004012

Brand Name

Mariner MCT

Version/Model Number

MC2-004012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 2022

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

ad18d4ea-1c63-4d93-b83d-4b824aba1fc2

Public Version Date

April 19, 2022

Public Version Number

4

DI Record Publish Date

January 09, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEASPINE ORTHOPEDICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5602
2 A medical device with a moderate to high risk that requires special controls. 14020
U Unclassified 21