TruMatch Personalised Solutions Shoulder System 225501002

GUDID 05420060363047

TRUMATCH SHOULDER PSI APG SCAPULA MODEL

Materialise NV

Custom-made organ/bone anatomy model

• Primary Device ID: 05420060363047
• NIH Device Record Key: 9f9a4fa8-dba8-4c66-b200-1499fa85b98d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruMatch Personalised Solutions Shoulder System
• Version Model Number: 225501002
• Catalog Number: 225501002
• 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: true
• 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	05420060363047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172054

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

[05420060363047]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-05-14

On-Brand Devices [TruMatch Personalised Solutions Shoulder System]

• 05420060363122: TRUMATCH SHOULDER PSI XTEND GUIDE+GRAFT MODEL
• 05420060363115: TRUMATCH SHOULDER PSI STEPTECH GUIDE+GRAFT MODEL
• 05420060363108: TRUMATCH SHOULDER PSI APG GUIDE+GRAFT MODEL
• 05420060363092: TRUMATCH SHOULDER PSI XTEND GUIDE
• 05420060363085: TRUMATCH SHOULDER PSI STEPTECH GUIDE
• 05420060363078: TRUMATCH SHOULDER PSI APG GUIDE
• 05420060363061: TRUMATCH SHOULDER PSI XTEND SCAPULA MODEL
• 05420060363054: TRUMATCH SHOULDER PSI STEPTECH SCAPULA MODEL
• 05420060363047: TRUMATCH SHOULDER PSI APG SCAPULA MODEL
• 05420060363191: Guide and Bone model Shoulder Arthroplasty 3.5mm Center Pin