Mariner MIS MM1-000010

GUDID 10889981288440

MIS POLYAXIAL HEAD, OPEN

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10889981288440
NIH Device Record Keya9ca29e0-ea25-4f65-9839-54d9d586c016
Commercial Distribution StatusIn Commercial Distribution
Brand NameMariner MIS
Version Model NumberMM1-000010
Catalog NumberMM1-000010
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981288440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981288440]

Moist Heat or Steam Sterilization


[10889981288440]

Moist Heat or Steam Sterilization


[10889981288440]

Moist Heat or Steam Sterilization


[10889981288440]

Moist Heat or Steam Sterilization


[10889981288440]

Moist Heat or Steam Sterilization


[10889981288440]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-01
Device Publish Date2022-05-24

On-Brand Devices [Mariner MIS]

10889981213688Handle
10889981230647Fascial Blade Caddy
10889981221188Mariner MIS Navigation Tray, Level 1
10889981221171Mariner MIS Navigation Tray
10889981221164MIS 6.0 Rod Caddy
10889981221157MIS Set Screw Caddy
10889981221140MIS 6.0 Constrained Rod Caddy
10889981221133MIS Head Caddy
10889981221126MIS Rod Caddy
10889981221119Mariner MIS Implant Tray, Level 2
10889981221102Mariner MIS Implant Tray, Level 1
10889981221096Mariner MIS Implant Tray
10889981221089Mariner MIS Instrument Tray 2, Level 2
10889981221072Mariner MIS Instrument Tray 2, Level 1
10889981221065Mariner MIS Instrument Tray 2
10889981221058Mariner MIS Instrument Tray 1, Level 2
10889981221041Mariner MIS Instrument Tray 1, Level 1
10889981221034Mariner MIS Instrument Tray 1
10889981218546CD Main Arm
10889981218539CD Extended Tab Arm
10889981218522CD Tower Arm
10889981218515CD Driver
10889981218492MIS Straight Rod, 6.0 x 450MM
10889981218485MIS Straight Rod, 6.0 x 400MM
10889981218478MIS Straight Rod, 6.0 x 350MM
10889981218461MIS Straight Rod, 6.0 x 300MM
10889981218454MIS Straight Rod, 6.0 x 250MM
10889981218447MIS Straight Rod, 6.0 x 240MM
10889981218430MIS Straight Rod, 6.0 x 230MM
10889981218423MIS Straight Rod, 6.0 x 220MM
10889981218416MIS Straight Rod, 6.0 x 210MM
10889981218409MIS Straight Rod, 6.0 x 200MM
10889981218393MIS Straight Rod, 6.0 x 190MM
10889981218386MIS Straight Rod, 6.0 x 180MM
10889981218379MIS Straight Rod, 6.0 x 170MM
10889981218362MIS Straight Rod, 6.0 x 160MM
10889981218355MIS Straight Rod, 6.0 x 150MM
10889981218348MIS Straight Rod, 6.0 x 140MM
10889981218331MIS Straight Rod, 6.0 x 130MM
10889981218324MIS Straight Rod, 6.0 x 120MM
10889981218317MIS Straight Rod, 6.0 x 110MM
10889981218300MIS Straight Rod, 6.0 x 100MM
10889981218294MIS Straight Rod, 6.0 x 95MM
10889981218287MIS Straight Rod, 6.0 x 90MM
10889981218270MIS Straight Rod, 6.0 x 85MM
10889981218263MIS Straight Rod, 6.0 x 80MM
10889981218256MIS Straight Rod, 6.0 x 75MM
10889981218249MIS Straight Rod, 6.0 x 70MM
10889981218232MIS Straight Rod, 6.0 x 65MM
10889981218225MIS Straight Rod, 6.0 x 60MM

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