Catalyst+ PT X4

GUDID 17350005280809

C-Rad Positioning AB

Laser patient positioning system

• Primary Device ID: 17350005280809
• NIH Device Record Key: ba4fedc8-6104-43c5-bee3-42b04a12d843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catalyst+ PT X4
• Version Model Number: SP003-0009
• Company DUNS: 509296997
• Company Name: C-Rad Positioning AB
• 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: false
• 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	17350005280809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200435

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2024-08-14
• Device Publish Date: 2024-08-06

Devices Manufactured by C-Rad Positioning AB

• 17350005280762 - Catalyst+: 2024-08-14
• 17350005280779 - Catalyst+ HD: 2024-08-14
• 17350005280786 - Catalyst+ HD Ring Gantry: 2024-08-14
• 17350005280793 - Catalyst+ PT: 2024-08-14
• 17350005280809 - Catalyst+ PT X4: 2024-08-14
• 17350005280809 - Catalyst+ PT X4: 2024-08-14
• 17350005280038 - Catalyst+: 2020-07-24
• 17350005280045 - Catalyst+: 2020-07-24
• 17350005280052 - HIT Laser: 2020-07-24 Laser Box Product Number: HW004 laser Product number: HW049