Mariner RDX MX2-000070

GUDID 10889981289874

Mariner RDX Tab Remover

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID10889981289874
NIH Device Record Key97fcdfff-deb0-472c-bc79-b146fe836a95
Commercial Distribution StatusIn Commercial Distribution
Brand NameMariner RDX
Version Model NumberMX2-000070
Catalog NumberMX2-000070
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
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
GS110889981289874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


[10889981289874]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-03
Device Publish Date2023-01-06

On-Brand Devices [Mariner RDX]

10889981289874Mariner RDX Tab Remover
10889981289867Mariner RDX Reamer
10889981289744Mariner RDX Locking Cap
10889981289829Mariner RDX Locking Cap Loader 2

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