Catalyst+ HY-004

GUDID 17350005280038

C-Rad Positioning AB

Laser patient positioning system

• Primary Device ID: 17350005280038
• NIH Device Record Key: 97c1a5e0-5cfd-4626-b5dc-13d7106347cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catalyst+
• Version Model Number: SP003
• Catalog Number: HY-004
• 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	17350005280038 [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
• 17350005280762: SP003-0001