MatrixNEURO 04503077
GUDID H980045030770
TI MATRIXNEURO CURVED STRUT PLATE/2 X 4 HOLE
SYNTHES (U.S.A.) LP
Craniofacial fixation plate, non-bioabsorbable| Primary Device ID | H980045030770 |
| NIH Device Record Key | f5a63278-ab8a-47f1-9613-907f49bfd910 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MatrixNEURO |
| Version Model Number | 04.503.077 |
| Catalog Number | 04503077 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10887587018096 [Primary] |
| HIBCC | H980045030770 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042365
FDA Product Code
| JEY | PLATE, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
[H980045030770]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [MatrixNEURO]
| H98004503115200 | TI MATRIXNEURO EMERGENCY SCREW 5MM |
| H98004503115050 | TI MATRIXNEURO EMERGENCY SCREW 5MM |
| H98004503114200 | TI MATRIXNEURO EMERGENCY SCREW 4MM |
| H98004503114050 | TI MATRIXNEURO EMERGENCY SCREW 4MM |
| H98004503113200 | TI MATRIXNEURO EMERGENCY SCREW 3MM |
| H98004503113050 | TI MATRIXNEURO EMERGENCY SCREW 3MM |
| H98004503105200 | TI MATRIXNEURO SCREW SELF-DRILLING 5MM |
| H98004503105050 | TI MATRIXNEURO SCREW SELF-DRILLING 5MM |
| H98004503104200 | TI MATRIXNEURO SCREW SELF-DRILLING 4MM |
| H98004503104050 | TI MATRIXNEURO SCREW SELF-DRILLING 4MM |
| H98004503103200 | TI MATRIXNEURO SCREW SELF-DRILLING 3MM |
| H98004503103050 | TI MATRIXNEURO SCREW SELF-DRILLING 3MM |
| H980605032400 | INSTRUMENT CASE FOR MATRIXNEURO MESH |
| H98004503158S0 | TI MATRIXNEURO PREFORMED MESH 109MM DIAMETER UNIVERSAL-STER |
| H98004503157S0 | TI MATRIXNEURO PREFORMED MESH 109MM X 78MM FRONTAL-STERILE |
| H98004503156S0 | TI MATRIXNEURO PREFORMED MESH 151MM X 125MM FTP/RIGHT-STER |
| H98004503155S0 | TI MATRIXNEURO PREFORMED MESH 151MM X 125MM FTP/LEFT-STERILE |
| H98004503152S0 | TI MATRIXNEURO PREFORMED MESH 99MMX66MM TEMPORAL/RIGHT-STER |
| H98004503151S0 | TI MATRIXNEURO PREFORMED MESH 99MM X 66MM TEMPORAL/LEFT-STER |
| H9803065460 | MATRIXNEURO ULP PLATE INSERT FOR MATRIXNEURO MODULE |
| H9803065410 | MATRIXNEURO RECON MESH IMPLANT INSERT FOR TRAY |
| H9803065400 | MATRIXNEURO RECON MESH INSTRUMENT INSERT FOR TRAY |
| H9803065330 | NEURO INSERT TRAY FOR MATRIXNEURO INSTR AND BPD |
| H9803065320 | NEURO INSERT TRAY FOR MATRIXNEURO INSTRUMENTS |
| H9803065210 | LID FOR COMPACT IMPLANT MODULE MATRIXNEURO SYSTEM |
| H9803065120 | SCREW INSERT FOR MATRIXNEURO IMPLANT MODULE |
| H9803065100 | MATRIXNEURO COMPACT MODULE BASE |
| H9803065070 | PLATE INSERT ADJUSTABLE FOR MATRIXNEURO IMPLANT MODULE |
| H9803065020 | MATRIXNEURO INSTRUMENT MODULE |
| H9803065010 | MATRIXNEURO COMPACT MODULE |
| H9803047890 | MATRIXNEURO RECON MESH TRAY LARGE/EXTRA DEEP |
| H98004503150S0 | TI MATRIXNEURO RECON MESH 100MM DIA/GOLD-STERILE |
| H98004503149S0 | TI MATRIXNEURO RECON MESH 70MM DIA/GOLD-STERILE |
| H98004503147S0 | TI MATRIXNEURO RECON MESH 200MM X 200MM/GOLD-STERILE |
| H98004503146S0 | TI MATRIXNEURO RECON MESH 150MM X 150MM/GOLD-STERILE |
| H98004503145S0 | TI MATRIXNEURO RECON MESH 100MM X 100MM/GOLD-STERILE |
| H98004503134S0 | MATRIXNEURO STERILE KIT 17MM BURR HOLE COVER/4MM |
| H98004503131S0 | MATRIXNEURO STERILE KIT STANDARD/4MM |
| H980045031270 | TI MATRIXNEURO CONTOUR MESH 100MM DIA/0.6MM RIGID |
| H980045031260 | TI MATRIXNEURO CONTOUR MESH 70MM DIA/0.6MM RIGID |
| H980045031250 | TI MATRIXNEURO CONTOUR MESH 30MM DIA/0.6MM RIGID |
| H980045031240 | TI MATRIXNEURO CONTOUR MESH LARGE ARC/0.6MM RIGID |
| H980045031230 | TI MATRIXNEURO CONTOUR MESH SMALL ARC/0.6MM RIGID |
| H98004503122S0 | TI MATRIXNEURO CONTOUR MESH 200MMX200MM/0.6MM-STERILE |
| H980045031220 | TI MATRIXNEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID |
| H980045031210 | TI MATRIXNEURO CONTOUR MESH 100MM X 100MM/0.6MM RIGID |
| H980045031200 | TI MATRIXNEURO CONTOUR MESH 38MM X 45MM/0.6MM RIGID |
| H98004503115010 | TI MATRIXNEURO EMERGENCY SCREW 5MM |
| H98004503114010 | TI MATRIXNEURO EMERGENCY SCREW 4MM |
| H98004503113010 | TI MATRIXNEURO EMERGENCY SCREW 3MM |
Trademark Results [MatrixNEURO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MATRIXNEURO 88266143 5871796 Live/Registered |
DePuy Synthes, Inc. 2019-01-17 |
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