SurgiCase OOS SurgiCase OOS

GUDID E314SURGICASEOOS0

SurgiCase OOS

Materialise NV

CAD/CAM software
Primary Device IDE314SURGICASEOOS0
NIH Device Record Keycafd4c80-0a9e-4e74-9414-8555130d8be8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiCase OOS
Version Model NumberSurgiCase OOS
Catalog NumberSurgiCase OOS
Company DUNS373139427
Company NameMaterialise NV
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
HIBCCE314SURGICASEOOS0 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-10

On-Brand Devices [SurgiCase OOS]

E314SURGICASEOOS0SurgiCase OOS
05404028000281SurgiCase Mobile

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