Mimics Viewer XR Mimics Viewer XR

GUDID 05404028000496

Mimics Viewer XR

Materialise NV

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

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05404028001172 - SurgiCase Online2026-03-31 SurgiCase Online
05404028001189 - ProPlan CMF 2026-03-31 ProPlan CMF Online
05404028000861 - Mimics Thoracic Planner2026-03-30 Mimics Thoracic Planner
05404028000830 - Mimics Automatic Algorithms2026-02-09 Mimics Automatic Algorithms CMF Orthognathic CT CBCT
05404028001042 - Mimics Automatic Algorithms 2026-02-09 Mimics Automatic Algorithms CMF Reconstruction CT CBCT
05404028001073 - Mimics Automatic Algorithms 2026-02-09 Mimics Automatic Algorithms Shoulder Arthroplasty CT
05404028001110 - SurgiCase Planner 2025-12-25 SurgiCase Shoulder Planner

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