TrueSight 5901-6102

GUDID 05420060362019

TSA guide and bone model

Materialise NV

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

• Primary Device ID: 05420060362019
• NIH Device Record Key: 06e22aad-6b8f-48c5-8b15-774350a7174b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueSight
• Version Model Number: 5901-6201
• Catalog Number: 5901-6102
• 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	05420060362019 [Primary]

FDA Product Code

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

Sterilization

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

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

[05420060362019]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-07-19

On-Brand Devices [TrueSight]

• 05420060361012: RSA guide and bone model
• 05420060362019: TSA guide and bone model