| Primary Device ID | H980035031660 | 
| NIH Device Record Key | fac91776-d6ec-4be0-ab5a-6f5d00d67f51 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MatrixMANDIBLE | 
| Version Model Number | 03.503.166 | 
| Catalog Number | 03503166 | 
| Company DUNS | 486711679 | 
| Company Name | Synthes GmbH | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 10887587012292 [Primary] | 
| HIBCC | H980035031660 [Secondary] | 
| HWT | TEMPLATE | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
[H980035031660]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 5 | 
| Public Version Date | 2022-04-25 | 
| Device Publish Date | 2016-12-31 | 
| H980035031850 | MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 2X2H TENSION BAND PL | 
| H980035031750 | MATRIXMANDIBLE BENDNG TEMPLATE F/2.0MM BROAD 3X3 ANGLE PLATE | 
| H980035031730 | MATRIXMANDIBLE BENDNG TEMPLATE F/2.0MM BROAD CRESCENT PLATES | 
| H980035031710 | MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM 6H CRESCENT PLATES | 
| H980035031700 | MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM THICK 3X3 ANGLE PLATE | 
| H980035031690 | MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM THK 3X3 STRAIGHT PLAT | 
| H980035031660 | MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM THICK ANGLE PLATES | 
| H980035031650 | MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 3X3 CRESCENT PLATES | 
| H980035031640 | MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 2X2 CRESCENT PLATES | 
| H980035031610 | MATRIXMANDIBLE BENDNG TEMPLATE F/1.0MM BROAD TENSION BAND PL | 
| H980035030700 | MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-SHORT | 
| H980035030690 | MATRIXMANDIBLE HOLDING SLEEVE LONG FOR USE WITH 03.503.068 | 
| 10887587034607 | GRAPHIC CASE MEDIUM FOR MATRIXMANDIBLE SYSTEM | 
| H980SD3178790 | MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/50MM | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MATRIXMANDIBLE  87315665  5399668 Live/Registered | DePuy Synthes, Inc. 2017-01-27 |