Mariner 90-3005

GUDID 10889981232368

Coronal Bender (R) 6.0

SEASPINE ORTHOPEDICS CORPORATION

Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable Manual orthopaedic bender, reusable
Primary Device ID10889981232368
NIH Device Record Keyc2f194fd-1327-4976-8a01-6eb8c6e41123
Commercial Distribution StatusIn Commercial Distribution
Brand NameMariner
Version Model Number90-3005
Catalog Number90-3005
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]
GS110889981232368 [Primary]

FDA Product Code

HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER
HXWBENDER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


[10889981232368]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [Mariner]

10889998163471Mariner 6.0 Tray, Insert 2
10889997163465Mariner 6.0 Tray, Insert 1
10889996163459Mariner 6.0 Tray, Base
10889995163443Sagittal Benders (R) 5.5
10889994163437Sagittal Benders (L) 5.5
10889993163421Coronal Bender (R) 5.5
10889992163415Coronal Benders (L) 5.5
10889991163409Sagittal Bender (R) 6.0
10889990163394Sagittal Benders (L) 6.0
10889989163381Coronal Benders (R) 6.0
10889988164730Rod Gripper 5.5/6.0
10889988163375Coronal Benders (L) 6.0
108899871633455.5mm X 500mm Rod Template
10889987163338Hex End Rod Rotator 5.5/6.0
10889981160050Adjustable Pedicle Screw Driver, Locking, 1/4 Sq
10889981160043Pedicle Screw Driver, Locking, Tri-Flat
10889981160036Pedicle Screw Driver, Locking, 1/4 sq
10889981160029Extended Trauma Head
10889981160012Extended Deformity Head
10889981160005Extended Polyaxial Head
10889981155131Trauma Head
10889981155124Deformity Head
10889981155117Polyaxial Head
10889981155100Set Screw
10889981149833Mariner Quick Release Reducer
10889981148195Precontoured CoCr Rod, 5.5 x 75mm
10889981148188Precontoured CoCr Rod, 5.5 x 65mm
10889981148171Precontoured CoCr Rod, 5.5 x 55mm
10889981148164Precontoured CoCr Rod, 5.5 x 45mm
10889981148157Precontoured CoCr Rod, 6.0 x 75mm
10889981148140Precontoured CoCr Rod, 6.0 x 65mm
10889981148133Precontoured CoCr Rod, 6.0 x 55mm
10889981148126Precontoured CoCr Rod, 6.0 x 45mm
10889981148102Precontoured ESS Plus Rod, 6.0 x 65mm
10889981148096Precontoured ESS Plus Rod, 6.0 x 55mm
10889981148089Precontoured ESS Plus Rod, 6.0 x 45mm
10889981148072Precontoured ESS Rod, 6.0 x 75mm
10889981148065Precontoured ESS Rod, 6.0 x 65mm
10889981148058Precontoured ESS Rod, 6.0 x 55mm
10889981148041Precontoured ESS Rod, 6.0 x 45mm
10889981147990Contoured Crossbar, Large, 6.0 Rod
10889981147983Contoured Crossbar, Medium, 6.0 Rod
10889981147976Contoured Crossbar, Small, 6.0 Rod
10889981147969Precontoured CoCr Rod, 6.0 x 600mm
10889981147952Precontoured CoCr Rod, 6.0 x 550mm
10889981147945Precontoured CoCr Rod, 6.0 x 500mm
10889981147938Precontoured CoCr Rod, 6.0 x 450mm
10889981147921Precontoured CoCr Rod, 6.0 x 400mm
10889981147914Precontoured CoCr Rod, 6.0 x 350mm
10889981147907Precontoured CoCr Rod, 6.0 x 300mm

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.