Mariner Outrigger 99-0007

GUDID 10889981172367

T-25 TAPERED INSERTER

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID10889981172367
NIH Device Record Key04d50625-22b3-4ba0-acaf-93459085214a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMariner Outrigger
Version Model Number99-0007
Catalog Number99-0007
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 Usefalse
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
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981172367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981172367]

Moist Heat or Steam Sterilization


[10889981172367]

Moist Heat or Steam Sterilization


[10889981172367]

Moist Heat or Steam Sterilization


[10889981172367]

Moist Heat or Steam Sterilization


[10889981172367]

Moist Heat or Steam Sterilization


[10889981172367]

Moist Heat or Steam Sterilization


[10889981172367]

Moist Heat or Steam Sterilization


[10889981172367]

Moist Heat or Steam Sterilization


[10889981172367]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-11
Device Publish Date2019-07-26

On-Brand Devices [Mariner Outrigger]

10889981213695Top Loading, Offset Caddy
10889981212025Box Chisel, Angled
10889981212018Box Chisel, Straight
10889981212001C-Chisel, Angled
10889981211998C-Chisel, Straight
10889981184995Parallel, Closed, Variable 8mm
10889981184988Parallel, Closed, Variable 8mm
10889981255886Fixed Axial Handle, Large, Impacting, Radel Core
10889981184889L-Con Caddy
10889981184872Z-Rod Caddy
10889981184865Gimbal Caddy
10889981184858Side-Loading Caddy
10889981184841Top Loading Caddy
10889981184834Closed/Closed Caddy
10889981184827Mariner Outrigger Implants
10889981184810Mariner Outrigger Instruments
10889981184803Mariner Outrigger Base
10889981172473Fixed Axial Handle, Midium, Impacting, Radel Core
10889981206390Counter Torque Handle
10889981172350Rasp
10889981184971Parallel, Top Loading/Closed, Variable 10mm
10889981184964Parallel, Top Loading/Closed, Variable 10mm
10889981184957Parallel, Side-Loading/Closed, Variable 8mm
10889981179984Z-Rod, Dia. 6.0mm, Co-Cr, 490mm
10889981179977Z-Rod, Dia. 6.0mm, Co-Cr, 480mm
10889981179960Z-Rod, Dia. 6.0mm, Co-Cr, 470mm
10889981179939Z-Rod, Dia. 6.0mm, Co-Cr, 430mm
10889981179922Z-Rod, Dia. 6.0mm, Co-Cr, 420mm
10889981179915Z-Rod, Dia. 6.0mm, Co-Cr, 410mm
10889981179892Z-Rod, Dia. 6.0mm, Co-Cr, 380mm
10889981179878Z-Rod, Dia. 6.0mm, Co-Cr, 360mm
10889981179861Z-Rod, Dia. 6.0mm, Co-Cr, 340mm
10889981179847Z-Rod, Dia. 6.0mm, Co-Cr, 320mm
10889981179830Z-Rod, Dia. 6.0mm, Co-Cr, 310mm
10889981179809Z-Rod, Dia. 6.0mm, Co-Cr, 270mm
10889981179793Z-Rod, Dia. 6.0mm, Co-Cr, 260mm
10889981179786Z-Rod, Dia. 6.0mm, Co-Cr, 240mm
10889981179779Z-Rod, Dia. 6.0mm, Co-Cr, 230mm
10889981179762Z-Rod, Dia. 6.0mm, Co-Cr, 220mm
10889981179755Z-Rod, Dia. 6.0mm, Co-Cr, 210mm
10889981179748Z-Rod, Dia. 6.0mm, Co-Cr, 190mm
10889981179731Z-Rod, Dia. 6.0mm, Co-Cr, 180mm
10889981179724Z-Rod, Dia. 6.0mm, Co-Cr, 170mm
10889981179694Z-Rod, Dia. 6.0mm, Co-Cr, 130mm
10889981179687Z-Rod, Dia. 6.0mm, Co-Cr, 120mm
10889981179670Z-Rod, Dia. 6.0mm, Co-Cr, 110mm
10889981179663Z-Rod, Dia. 6.0mm, Co-Cr, 90mm
10889981179656Z-Rod, Dia. 6.0mm, Co-Cr, 80mm
10889981179625Z-Rod, Dia. 6.0mm, Co-Cr, 50mm
10889981176198Z-Rod, Dia. 6.0mm, Titanium, 500mm

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