Mariner MCT MC1-200100

GUDID 10889987169934

Constrained Rod, 100mm, Precontoured

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10889987169934
NIH Device Record Key1bb965fd-7ebf-4141-bac9-b6d67049ee41
Commercial Distribution StatusIn Commercial Distribution
Brand NameMariner MCT
Version Model NumberMC1-200100
Catalog NumberMC1-200100
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110889987169934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889987169934]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-18
Device Publish Date2019-04-10

On-Brand Devices [Mariner MCT]

10889987169934Constrained Rod, 100mm, Precontoured
10889987169897Constrained Rod, 80mm, Precontoured
10889987169828Constrained Rod, 45mm, Precontoured
10889987170695Rod Holder
10889981195878Mariner Midline Retractor Tray, level 1
10889981195861Mariner Midline Retractor Tray - Base
10889981195854Mariner Midline Implant Tray - level 2
10889981195847Mariner Midline Implant Tray - level 1
10889981195830Mariner Midline Implant Tray - Base
10889981195823Mariner Midline Instrument Tray 2 - level 2
10889981195816Mariner Midline Instrument Tray 2 - level 1
10889981195809Mariner Midline Instrument Tray 2 - Base
10889981195793Mariner Midline Instrument Tray 1 - level 2
10889981195786Mariner Midline Instrument Tray 1 - level 1
10889981195779Mariner Midline Tray 1 - Base
10889981189440Shank Inserter, Self-retaining, Short
10889981189433Shank Inserter, Self-retaining
10889981195908Mariner Midline Constrained Rod Caddy
10889981195892Mariner Midline Shank Caddy Lid
10889981195885Mariner Midline Shank Caddy
10889981230517Light Cable Adapter, ACMI
10889981170691Rod Holder
10889981170301Counter Torque, Slim
10889981170295Compressor, Slim
10889981170288Rod Measurement Wand
10889981170271Slim Head Inserter, Long
10889981170264Slim Head Inserter, Short
10889981170240Face-cutting Reamer, T-Handle
10889981170233Face-cutting Reamer, Tri-flat
10889981170226Face-cutting Reamer, A/O
10889981170219Face-cutting Reamer, 1/4"Quick-connect
108899811702024.0mm Drill, Solid, Tri-Flat
108899811701964.0mm Drill, Solid, A/O QC
108899811701894.0mm Drill, Solid, 1/4" QC
108899811701723.5mm Drill, Solid, Tri-Flat
108899811701653.5mm Drill, Solid, A/O QC
108899811701583.5mm Drill, Solid, 1/4" QC
108899811701413.0mm Drill, Solid, Tri-Flat
108899811701343.0mm Drill, Solid, A/O QC
108899811701273.0mm Drill, Solid, 1/4" QC
10889981170110Cortical Screw Shank Driver, Long
10889981170103Cortical Screw Shank Driver, Short
10889981170097Cortical Screw Shank Driver
108899811700806.5mm Tap, Cortical, Cannulated
108899811700736.0mm Tap, Cortical, Cannulated
108899811700665.5mm Tap, Cortical, Cannulated
108899811700595.0mm Tap, Cortical, Cannulated
108899811700424.5mm Tap, Cortical, Cannulated
10889981170035Adjustable Drill Guide
108899811700286.5mm Tap, Cortical, Solid

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