Mimics Viewer XR Mimics Viewer XR

GUDID 05404028000496

Mimics Viewer XR

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 ID05404028000496
NIH Device Record Key30d992b6-c35e-4ef1-a846-5349834cb026
Commercial Distribution StatusIn Commercial Distribution
Brand NameMimics Viewer XR
Version Model NumberMimics Viewer XR
Catalog NumberMimics Viewer XR
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
GS105404028000496 [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 Date2023-05-10
Device Publish Date2023-05-02

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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