TrueSight 5901-6101

GUDID 05420060361012

RSA guide and bone model

Materialise NV

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

• Primary Device ID: 05420060361012
• NIH Device Record Key: 292c0f72-9680-4e02-bc88-d517d821e32d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueSight
• Version Model Number: 5901-6101
• Catalog Number: 5901-6101
• 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	05420060361012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153602

FDA Product Code

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

Sterilization

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

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

[05420060361012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-24

On-Brand Devices [TrueSight]

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