Catalyst+ HY-005

GUDID 17350005280045

C-Rad Positioning AB

Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system Laser patient positioning system

• Primary Device ID: 17350005280045
• NIH Device Record Key: fd88058f-0ea4-41aa-bafd-ca80dad3baca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catalyst+
• Version Model Number: SP003
• Catalog Number: HY-005
• 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

Customer Support Contacts

• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se
• Phone: 5617429260
• Email: support@c-rad.se

Device Identifiers

Device Issuing Agency	Device ID
GS1	17350005280045 [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: 2020-07-24
• Device Publish Date: 2020-07-16

On-Brand Devices [Catalyst+]

• 17350005280045: SP003
• 17350005280038: SP003