CAS-One IR

GUDID 07640167222131

CAScination AG

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 07640167222131
• NIH Device Record Key: 9403d410-0848-46b4-b5f9-549c60b2fb8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAS-One IR
• Version Model Number: 2.0
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	07640167222131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152473

FDA Product Code

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

Sterilization

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

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

[07640167222131]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-21
• Device Publish Date: 2022-06-10

Devices Manufactured by CAScination AG

• 07640167222414 - OTOPLAN: 2022-07-19
• 07640167222131 - CAS-One IR: 2022-06-21
• 07640167222131 - CAS-One IR: 2022-06-21
• 07640167220724 - OTOPLAN: 2022-04-27