SurgiCase Viewer SurgiCase Viewer

GUDID E314SURGICASEVIEWER0

SurgiCase Viewer

Materialise NV

CAD/CAM software
Primary Device IDE314SURGICASEVIEWER0
NIH Device Record Keya7d94176-82bf-4260-9a64-a65815ffb5fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiCase Viewer
Version Model NumberSurgiCase Viewer
Catalog NumberSurgiCase Viewer
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
HIBCCE314SURGICASEVIEWER0 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-16

Devices Manufactured by Materialise NV

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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

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