Mimics Enlight Mimics Enlight Medical

GUDID E314MIMICSENLIGHTMED0

Mimics Enlight Medical

Materialise NV

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software
Primary Device IDE314MIMICSENLIGHTMED0
NIH Device Record Key16750a35-4bf6-4d74-ac42-c94c1bcb7751
Commercial Distribution StatusIn Commercial Distribution
Brand NameMimics Enlight
Version Model NumberMimics Enlight Medical
Catalog NumberMimics Enlight Medical
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE314MIMICSENLIGHTMED0 [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 Date2019-09-05
Device Publish Date2019-08-28

Devices Manufactured by Materialise NV

05404028000571 - Mimics Cardiac Planner2024-03-25 Mimics Cardiac Planner
05420060367052 - AtlasPlan2023-12-27 Bone model for Reverse Shoulder Arthroplasty Aetos
05420060367069 - AtlasPlan2023-12-27 Guide and Bone model for Reverse Shoulder Arthroplasty Aetos
05420060367076 - AtlasPlan2023-12-27 Guide for Reverse Shoulder Arthroplasty Aetos
05420060367083 - AtlasPlan2023-12-27 Guide and Bone model for Total Shoulder Arthroplasty Aetos
05420060367090 - AtlasPlan2023-12-27 Guide for Total Shoulder Arthroplasty Aetos
05420060367106 - AtlasPlan2023-12-27 Bone model for Total Shoulder Arthroplasty Aetos
05404028000724 - Mimics2023-12-26 Mimics Automatic Algorithms Ankle CT

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