Materialise Personalized Solutions O-01-0-300000-0121-020

GUDID 05420060343254

Bone Model Lower Extremity

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit

• Primary Device ID: 05420060343254
• NIH Device Record Key: 926a8512-dbb2-4061-befb-061976bbac5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Materialise Personalized Solutions
• Version Model Number: O-01-0-300000-0121-020
• Catalog Number: O-01-0-300000-0121-020
• Company DUNS: 373139427
• Company Name: Materialise NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420060343254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112389

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

[05420060343254]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-19
• Device Publish Date: 2023-07-11

On-Brand Devices [Materialise Personalized Solutions]

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