CAS-One IR Consumable Set General 50002

GUDID 17640167220028

CAScination AG

Surgical optical-tracking spatial marker, single-use

• Primary Device ID: 17640167220028
• NIH Device Record Key: 903f8ae0-1d03-4a6f-b23b-775d28b038d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAS-One IR Consumable Set General
• Version Model Number: 2.0
• Catalog Number: 50002
• Company DUNS: 485258433
• Company Name: CAScination AG
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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	07640167220021 [Primary]
GS1	17640167220028 [Package]; Contains: 07640167220021; Package: Cardboard Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232022

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-25
• Device Publish Date: 2024-06-17

Devices Manufactured by CAScination AG

• 07616962000212 - OTOPLAN: 2025-06-20
• 17640167220028 - CAS-One IR Consumable Set General: 2024-06-25
• 17640167220028 - CAS-One IR Consumable Set General: 2024-06-25
• 07616962000250 - CAS-One IR Software: 2024-06-17
• 07640167222414 - OTOPLAN: 2022-07-19
• 07640167222131 - CAS-One IR: 2022-06-21
• 07640167220724 - OTOPLAN: 2022-04-27