Materialise Mimics Enlight Materialise Mimics Enlight

GUDID 05404028000199

Materialise Mimics Enlight

Materialise NV

CAD/CAM software
Primary Device ID05404028000199
NIH Device Record Key0d175656-312f-4b1d-8de0-d45215af06cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaterialise Mimics Enlight
Version Model NumberMaterialise Mimics Enlight
Catalog NumberMaterialise Mimics Enlight
Company DUNS373139427
Company NameMaterialise NV
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105404028000199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-17
Device Publish Date2025-03-07

Devices Manufactured by Materialise NV

05420060380792 - TRUMATCH2025-09-19 TRUMATCH TJR Mandible Polyamide Kit
05420060380808 - TRUMATCH2025-09-19 TRUMATCH TJR Mandible Polyamide Kit with duplicate bridge
05420060380815 - TRUMATCH2025-09-19 TRUMATCH TJR Midface Polyamide Kit
05420060380822 - TRUMATCH2025-09-19 TRUMATCH TJR Midface Polyamide Kit with duplicate bridge
05420060380839 - TRUMATCH2025-09-19 TRUMATCH TJR Mandible Titanium Kit
05420060380846 - TRUMATCH2025-09-19 TRUMATCH TJR Mandible Titanium Kit with duplicate bridge
05420060380853 - TRUMATCH2025-09-19 TRUMATCH TJR Midface Titanium Kit
05420060380860 - TRUMATCH2025-09-19 TRUMATCH TJR Midface Titanium Kit with duplicate bridge

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