SurgiCase Planner SurgiCase Planner

GUDID E314SURGICASEPLANNER0

SurgiCase Planner

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 IDE314SURGICASEPLANNER0
NIH Device Record Keyd38de10d-d11c-43a7-b426-e20d2273a4c5
Commercial Distribution Discontinuation2020-01-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSurgiCase Planner
Version Model NumberSurgiCase Planner
Catalog NumberSurgiCase Planner
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
HIBCCE314SURGICASEPLANNER0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-03
Device Publish Date2017-02-10

On-Brand Devices [SurgiCase Planner]

E314SURGICASESHOULPLAN0SurgiCase Shoulder Planner
E314SURGICASEPLANNER0SurgiCase Planner
E314SURGICASEKNEEPLAN0SurgiCase Knee Planner

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