TruMatch SD980.113
GUDID 05420060381133
TRUMATCH Midface/Mandible - Titanium 3D Printed Implant for Orbit, Thin
Materialise NV
Cranial bone prosthesis, custom-made| Primary Device ID | 05420060381133 |
| NIH Device Record Key | 190a5c26-2ed4-45aa-952d-c942b2f51a93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruMatch |
| Version Model Number | SD980.113 |
| Catalog Number | SD980.113 |
| Company DUNS | 373139427 |
| Company Name | Materialise NV |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05420060381133 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170272
FDA Product Code
| JEY | Plate, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
[05420060381133]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-09 |
| Device Publish Date | 2020-07-01 |
On-Brand Devices [TruMatch]
| 05420060381119 | TRUMATCH Midface/Mandible - Titanium 3D Printed Orbital kit, without planning |
| 05420060381102 | TRUMATCH Midface/Mandible - Titanium 3D Printed Orbital kit |
| 05420060381096 | TRUMATCH TI Implant - Mandible - large |
| 05420060381089 | TRUMATCH TI Implant - Mandible - medium |
| 05420060381072 | TRUMATCH TI Implant - Mandible -small |
| 05420060381065 | TRUMATCH TI Implant - Midface Small |
| 05420060381058 | TRUMATCH TI Implant - Midface Large |
| 05420060381034 | TRUMATCH Midface/Mandible - Titanium 3D Printed Implant for Orbit |
| 05420060381027 | TRUMATCH Midface/Mandible - Titanium 3D Printed Implant for Orbit |
| 05420060380211 | TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Large |
| 05420060380204 | TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Medium |
| 05420060380198 | TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Small |
| 05420060380181 | TRUMATCH Midface/Mandible - Zygomatic Surgical Kit |
| 05420060380174 | TRUMATCH Midface/Mandible - Titanium 3D Printed Guide for Mandible |
| 05420060380167 | TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Mini |
| 05420060380150 | TRUMATCH Midface/Mandible - Titanium 3D Printed Guide for Midface |
| 05420060380143 | TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Midface |
| 05420060380136 | TTRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on |
| 05420060380129 | TRUMATCH Orthognathics - Basic Mandibular Surgical Kit, without Planning |
| 05420060380112 | TRUMATCH Orthognathics - Basic Mandibular Surgical Kit |
| 05420060380105 | TRUMATCH Orthognathics - Full Mandibular Surgical Kit, without planning |
| 05420060380099 | TRUMATCH Orthognathics - Full Mandibular Surgical Kit |
| 05420060380082 | TRUMATCH Orthognathics - Basic Maxillary Surgical Kit, without Planning |
| 05420060380075 | TRUMATCH Orthognathics - Basic Maxillary Surgical Kit |
| 05420060380068 | TRUMATCH Orthognathics - Full Maxillary Surgical Kit, without planning |
| 05420060380051 | TRUMATCH Orthognathics - Full Maxillary Surgical Kit |
| 05420060380044 | TRUMATCH Orthognathics - Basic Bimaxillary Surgical Kit, without Planning |
| 05420060380037 | TRUMATCH Orthognathics - Basic Bimaxillary Surgical Kit |
| 05420060380020 | TRUMATCH Orthognathics - Full Bimaxillary Surgical Kit, without planning |
| 05420060380013 | TRUMATCH Orthognathics - Full Bimaxillary Surgical Kit |
| 05420060381041 | TRUMATCH Midface/Mandible - Titanium 3D Printed Guide for Orbit |
| 05420060381133 | TRUMATCH Midface/Mandible - Titanium 3D Printed Implant for Orbit, Thin |
Trademark Results [TruMatch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUMATCH 98593085 not registered Live/Pending |
Depuy Synthes, Inc. 2024-06-10 |
 TRUMATCH 90594150 not registered Live/Pending |
Central Coated Products, Inc. 2021-03-22 |
 TRUMATCH 87024972 5267135 Live/Registered |
DANIEL ALAIN, INC. 2016-05-04 |
 TRUMATCH 86721693 not registered Dead/Abandoned |
TruMid Financial LLC 2015-08-11 |
 TRUMATCH 86668088 not registered Dead/Abandoned |
AS IP Holdco, LLC 2015-06-19 |
 TRUMATCH 85974438 4602779 Live/Registered |
Owens Corning Intellectual Capital LLC 2013-07-01 |
 TRUMATCH 85685877 4308670 Dead/Cancelled |
Gibbs, William 2012-07-24 |
 TRUMATCH 85432889 not registered Dead/Abandoned |
Federal-Mogul Products, Inc. 2011-09-27 |
 TRUMATCH 77695103 3776089 Live/Registered |
DEPUY SYNTHES, INC. 2009-03-19 |
 TRUMATCH 77074568 3627509 Live/Registered |
DHI CORP. 2007-01-02 |
 TRUMATCH 75894323 2764638 Live/Registered |
DENTSPLY SIRONA INC. 2000-01-12 |
 TRUMATCH 74037438 1735563 Live/Registered |
TRUMATCH SYSTEMS 1990-03-12 |
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