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

05420060366116 - Match Point System2024-12-17 Guide and Bone model for Reverse Shoulder Arthroplasty (AltiVate® Reverse)
05420060366123 - Match Point System2024-12-17 Guide and Bone model for Total Shoulder Arthroplasty (AltiVate® Full Wedge)
05404028000090 - Mimics2024-12-11 Mimics Automatic Algorithms Knee MRI
05404028000335 - Mimics2024-12-11 Mimics Automatic Algorithms Heart CT
05404028000359 - Mimics2024-12-11 Mimics Automatic Algorithms Knee CT
05404028000700 - 3-matic2024-12-11 3-matic Medical
05404028000717 - Mimics2024-12-11 Mimics Medical
05404028000885 - Mimics Plugin2024-12-11 Mimics Plugin GRP Plugin

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