MATRIXWAVE 0450382405
GUDID H98004503824050
MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM LENGTH
SYNTHES (U.S.A.) LP
Orthopaedic bone screw, non-bioabsorbable, non-sterile| Primary Device ID | H98004503824050 |
| NIH Device Record Key | bd2cadf4-7983-476f-a2ad-b85911bcc12a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MATRIXWAVE |
| Version Model Number | 04.503.824.05 |
| Catalog Number | 0450382405 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 5 |
| 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 |
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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 |
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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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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20887587069491 [Primary] |
| GS1 | 80887587069493 [Unit of Use] |
| HIBCC | H98004503824050 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141165
FDA Product Code
| JEY | PLATE, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
Moist Heat or Steam Sterilization
[H98004503824050]
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 [MATRIXWAVE]
| H98004503825050 | MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH |
| H98004503824050 | MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM LENGTH |
| 07612334093486 | MATRIXWAVE MMF APPLICATION INSTRUMENT |
| H98004503825010 | MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH |
| H98004503824010 | MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM LENGTH |
| H980045038210 | MATRIXWAVE MMF TI PLATE 10 HOLES/TALL |
| H980045038200 | MATRIXWAVE MMF TI PLATE 10 HOLES/SHORT |
| 07612334094780 | MATRIXWAVE MMF SYSTEM INSERT TRAY ID TAG F/PLATES |
| 07612334094773 | MATRIXWAVE MMF INSERT TRAY ID TAG F/1.85MM LOCKING SCREWS |
| 07612334094766 | MATRIXWAVE MMF SYSTEM INSERT TRAY F/1.85MM LOCKING SCREWS |
| 07612334094759 | MATRIXWAVE MMF SYSTEM IMPLANT MODULE ID TAG |
| 07612334093547 | MATRIXWAVE MMF SYSTEM INSTRUMENT MODULE ID TAG |
| 07612334093530 | MATRIXWAVE MMF SYSTEM MODULE LID |
| 07612334093523 | MATRIXWAVE MMF SYSTEM IMPLANT MODULE BASE |
| 07612334093516 | MATRIXWAVE MMF SYSTEM INSTRUMENT MODULE BASE |
Trademark Results [MATRIXWAVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MATRIXWAVE 86318318 4823301 Live/Registered |
DePuy Synthes, Inc. 2014-06-24 |
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