SurgiCase OOS SurgiCase Mobile

GUDID 05404028000281

SurgiCase Mobile

Materialise NV

CAD/CAM software
Primary Device ID05404028000281
NIH Device Record Keyc0c447d7-28c8-4bb0-9b36-a1f94bc555e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiCase OOS
Version Model NumberSurgiCase Mobile
Catalog NumberSurgiCase Mobile
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 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
GS105404028000281 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-17
Device Publish Date2025-03-07

On-Brand Devices [SurgiCase OOS]

E314SURGICASEOOS0SurgiCase OOS
05404028000281SurgiCase Mobile

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