General SR0116
GUDID 10889981143497
Dilator 5 Threaded File
SEASPINE ORTHOPEDICS CORPORATION
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 10889981143497 |
| NIH Device Record Key | ce634fbc-f2eb-4d38-8c8f-73f85155683c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | General |
| Version Model Number | SR0116 |
| Catalog Number | SR0116 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981143497 [Primary] |
FDA Product Code
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
[10889981143497]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
On-Brand Devices [General]
| 10889981144296 | Palm Style Probe |
| 10889981144265 | 3.5mm Tap File |
| 10889981143497 | Dilator 5 Threaded File |
| 10889981140267 | Locking Driver, Free Sleeve |
| 10889981159474 | TruProfile Plate Caddy |
| 10889981143343 | Slap Hammer, 3/8 Male |
| 10889981289362 | Suction Tip, #10 |
| 10889981289355 | Suction Tip, #8 |
| 10889981286934 | Alpha Universal Lid, 20 X 10 |
| 10889981325107 | Meridian 4-Hole No-Profile Instrument Tray Level 1 |
| 10889981325091 | Meridian 4-Hole No-Profile Instrument Tray Case |
| 10889981310240 | Meridian Trial Rasp Tray |
| 10889981308896 | Lattus Tray - Top Level |
| 10889981308889 | Lattus Tray - Base Level |
| 10889981300357 | MIS Retractor Tray Level 2 |
| 10889981300340 | MIS Retractor Tray Level 1 |
| 10889981300333 | MIS Retractor Tray Case |
| 10889981300142 | Mariner RDX MIS Tray |
| 10889981296988 | Mariner Deformity Rod Tray |
| 10889981296827 | Mariner Deformity Uni-Axial Screw Tray Base |
| 10889981296803 | Mariner Deformity Uni-Planar Screw Tray Base |
| 10889981296667 | Mariner Deformity Implant Tray Bottom Insert |
| 10889981296650 | Mariner Deformity Implant Tray Top Insert |
| 10889981296643 | Mariner Deformity Implant Tray Base |
| 10889981291273 | Manta Ray TDF Tray |
| 10889981289263 | BOTTOM TRAY |
| 10889981286033 | Facet Prep Instrumentation Tray ? Lid, Lumbar |
| 10889981286026 | Facet Prep Instrumentation Tray ? Base, Lumbar |
| 10889981277574 | ACP Tray Case, ASC |
| 10889981277444 | ACP Misc Tray (4/5 Level Plate & Misc Tray) |
| 10889981277437 | ACP Implant Tray (Plate & Screw Tray) |
| 10889981277420 | ACP Fixation Tray (Prep & Insertion Tray) |
| 10889981276461 | Shoreline TruProfile Plate Tray |
| 10889981276140 | NewPort Instrument Tray 2, Level 2 |
| 10889981276133 | NewPort Instrument Tray 2 |
| 10889981260170 | NewPort Implant Tray, Level 2 |
| 10889981260163 | NewPort Instrument Tray 1 |
| 10889981260156 | Navigation Tray Insert |
| 10889981260149 | Navigation Tray Case |
| 10889981255633 | Daytona Auxiliary Tray |
| 10889981247805 | NewPort Implant Tray, Level 1 |
| 10889981247799 | NewPort Implant Tray |
| 10889981247782 | Malibu 8.0+ Instrument Tray |
| 10889981247768 | NewPort Instrument Tray 2, Level 1 |
| 10889981247751 | Malibu Hook Instrument Tray |
| 10889981221508 | NewPort Instrument Tray 1, Level 2 |
| 10889981221492 | Inner Tray Lid |
| 10889981221485 | Malibu Implant Tray Lid |
| 10889981221478 | Malibu Implant Tray 1 Inner Tray 2 |
| 10889981221461 | Malibu Implant Tray 1 Inner Tray 1 |
Trademark Results [General]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENERAL 97750535 not registered Live/Pending |
GREENFIELD WORLD TRADE, INC. 2023-01-11 |
 GENERAL 88900715 not registered Live/Pending |
General Equipment Company 2020-05-05 |
 GENERAL 88884778 not registered Live/Pending |
SPORTS WAGERING ANALYTICS, INC. 2020-04-23 |
 GENERAL 88736340 not registered Live/Pending |
K&C AMERICA LLC 2019-12-21 |
 GENERAL 88727189 not registered Live/Pending |
K&C AMERICA LLC 2019-12-13 |
 GENERAL 88629178 not registered Live/Pending |
GENERAL PUMPS S.L. 2019-09-24 |
 GENERAL 88222875 not registered Live/Pending |
Polaris Industries Inc. 2018-12-10 |
 GENERAL 87552539 not registered Dead/Abandoned |
General Foundries, Inc. 2017-08-02 |
 GENERAL 86658042 4846169 Live/Registered |
REPUBLIC FORGE, LLC 2015-06-10 |
 GENERAL 85878950 4490523 Live/Registered |
General Paint Co. S.A.L. 2013-03-18 |
 GENERAL 85276444 4240099 Dead/Cancelled |
Genfloor, LLC 2011-03-25 |
 GENERAL 85202888 4107604 Dead/Cancelled |
Swedish Match North Europe AB 2010-12-21 |
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