Materialise Personalized Solutions O-01-0-105000-0011-010

GUDID 05420060343285

Humerus Osteotomy Guide and Model

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit
Primary Device ID05420060343285
NIH Device Record Key017c9bc0-d5b9-4dd8-a7be-f8e6cf507e20
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaterialise Personalized Solutions
Version Model NumberO-01-0-105000-0011-010
Catalog NumberO-01-0-105000-0011-010
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105420060343285 [Primary]
HIBCCE314O01010500000110100 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBFOrthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


[05420060343285]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-19
Device Publish Date2023-07-11

On-Brand Devices [Materialise Personalized Solutions]

05420060343407Lower extremity Guide and Model
05420060343391Upper Extremity Guide and Model
05420060343360Acromion Osteotomy Guide and Model
05420060343346Pediatric Radius/Ulna Model
05420060343322Femur Osteotomy Guide and Model
05420060343315Tibia/Fibula Osteotomy Guide and Model
05420060343308Clavicle Osteotomy Guide and Model
05420060343292Hand Osteotomy Guide and Model
05420060343285Humerus Osteotomy Guide and Model
05420060343278Pediatric Radius/Ulna Osteotomy Guide and Model
05420060343261Radius/Ulna Osteotomy Guide and Model
05420060343254Bone Model Lower Extremity
05420060343247Bone Model Upper Extremity
05420060343230Acromion Osteotomy Model
05420060343223Acromion Osteotomy Guide
05420060343209Guide Lower Extremity
05420060343186Guide Upper Extremity
05420060343148Bone Model
05420060343117Femur Osteotomy Model
05420060343100Femur Osteotomy Guide
05420060343094Tibia/Fibula Osteotomy Model
05420060343087Tibia/Fibula Osteotomy Guide
05420060343070Clavicle Osteotomy Model
05420060343063Clavicle Osteotomy Guide
05420060343056Hand Osteotomy Model
05420060343049Hand Osteotomy Guide
05420060343032Humerus Osteotomy Model
05420060343025Humerus Osteotomy Guide
05420060343018Radius/Ulna Osteotomy Model
05420060343001Radius/Ulna Osteotomy Guide

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