VISIONAIRE UNI V0500001

GUDID 00885556700167

NONSTERILE VISIONAIRE UNI CUTTING GUIDE

Materialise NV

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

• Primary Device ID: 00885556700167
• NIH Device Record Key: ca647895-ae09-42a9-854d-f9c82bf56c05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONAIRE UNI
• Version Model Number: V0500001
• Catalog Number: V0500001
• 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	00885556700167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172650

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

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

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

Moist Heat or Steam Sterilization

[00885556700167]

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: 2018-04-10

On-Brand Devices [VISIONAIRE UNI]

• 00885556700204: NONSTERILE VISIONAIRE UNI BONE MODEL
• 00885556700167: NONSTERILE VISIONAIRE UNI CUTTING GUIDE