Access Arm Support RT-4546AA-01

GUDID 00841962119504

Access Arm Support

Qfix

Radiological breast positioner, non-wearable

• Primary Device ID: 00841962119504
• NIH Device Record Key: af2baec8-f37b-47f9-9aaf-31bca86ba177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Arm Support
• Version Model Number: RT-4546AA-01
• Catalog Number: RT-4546AA-01
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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	00841962119504 [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

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• 00841962119474 - Alpine Stirrups: 2025-07-17 Stirrup, Right
• 00841962119481 - Symphony™: 2025-07-17 Alta AirShuttle Upgrade
• 00841962119498 - AirDrive Trolley™: 2025-07-17 AirDrive Trolley IV Pole
• 00841962119504 - Access Arm Support: 2025-07-17Access Arm Support
• 00841962119504 - Access Arm Support: 2025-07-17 Access Arm Support
• 00841962119511 - Access Wrist Support: 2025-07-17 Access Wrist Support
• 00841962119528 - AirShuttle Locating Bar: 2025-07-17 AirShuttle Locating Bar, Elekta Compatible