MatrixMANDIBLE 04497001
GUDID H980044970010
SLOTTED SCREW F/CONDYLAR HEAD ADD-ON SYS F/MATRIXMANDIBLE
SYNTHES (U.S.A.) LP
Temporary mandibular condyle prosthesis| Primary Device ID | H980044970010 |
| NIH Device Record Key | ac24dc48-9c33-4ac4-98be-ebb0e0913c1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MatrixMANDIBLE |
| Version Model Number | 04.497.001 |
| Catalog Number | 04497001 |
| 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 |
| 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 | 10887587016443 [Primary] |
| HIBCC | H980044970010 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081747
FDA Product Code
| NEI | Prosthesis, condyle, mandibular, temporary |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
Moist Heat or Steam Sterilization
[H980044970010]
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 [MatrixMANDIBLE]
| H98004503678200 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 18MM |
| H98004503678050 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 18MM |
| H98004503676200 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM |
| H98004503676050 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM |
| H98004503674200 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM |
| H98004503674050 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM |
| H98004503672200 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM |
| H98004503672050 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM |
| H98004503670200 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM |
| H98004503670050 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM |
| H98004503668200 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM |
| H98004503668050 | 2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM |
| H98004503648200 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 18MM |
| H98004503648050 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 18MM |
| H98004503646200 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM |
| H98004503646050 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM |
| H98004503644200 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM |
| H98004503644050 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM |
| H98004503642200 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM |
| H98004503642050 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM |
| H98004503640200 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM |
| H98004503640050 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM |
| H98004503638200 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM |
| H98004503638050 | 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM |
| H98004503618200 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 18MM |
| H98004503618050 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 18MM |
| H98004503616200 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM |
| H98004503616050 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM |
| H98004503614200 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM |
| H98004503614050 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM |
| H98004503612200 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM |
| H98004503612050 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM |
| H98004503610200 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM |
| H98004503610050 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM |
| H98004503608200 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM |
| H98004503608050 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM |
| H98004503606200 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM |
| H98004503606050 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM |
| H98004503605200 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 5MM |
| H98004503605050 | 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 5MM |
| H98004503558050 | 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 8MM |
| H98004503556050 | 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM |
| H98004503555050 | 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 5MM |
| H98004503554050 | 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 4MM |
| H98004503548050 | 2.0MM TI MATRIXMANDIBLE SCREW SELF-DRILLING/LOCKING/8MM |
| H98004503546050 | 2.0MM TI MATRIXMANDIBLE SCREW SELF-DRILLING/LOCKING/6MM |
| H98004503508050 | 2.0MM TI MATRIXMANDIBLE SCREW SELF-DRILLING/8MM |
| H98004503506050 | 2.0MM TI MATRIXMANDIBLE SCREW SELF-DRILLING/6MM |
| H98004503478200 | 2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 18MM |
| H98004503478050 | 2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 18MM |
Trademark Results [MatrixMANDIBLE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MATRIXMANDIBLE 87315665 5399668 Live/Registered |
DePuy Synthes, Inc. 2017-01-27 |
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