Opti-Handles RT-4454-14

GUDID 00841962119887

Opti-Handles, 14", set of 2

Qfix

Indexed-immobilization patient positioning system

• Primary Device ID: 00841962119887
• NIH Device Record Key: 44ae8578-9a49-4347-a328-527e3ac637b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opti-Handles
• Version Model Number: RT-4454-14
• Catalog Number: RT-4454-14
• Company DUNS: 808875397
• Company Name: Qfix
• 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: false
• 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: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841962119887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060671

FDA Product Code

• JAI: Couch, Radiation Therapy, Powered

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: 2025-07-17
• Device Publish Date: 2025-07-09

On-Brand Devices [Opti-Handles]

• 00841962119917: Opti-Handles, 45cm (18") set of 2
• 00841962119900: Opti-Handles, 60cm (24") set of 2
• 00841962119894: Opti-Handles 15cm (6in.) set of 2
• 00841962119887: Opti-Handles, 14", set of 2
• 00841962119870: Opti-Handles, 30cm (12"), set of 2