Alta™ RT-4800-01

GUDID 10841962110966

Alta™ Multipurpose Device

Qfix

Patient positioner base plate

• Primary Device ID: 10841962110966
• NIH Device Record Key: aef91be5-6d4a-44b0-ad36-4c9fb7ec2248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alta™
• Version Model Number: RT-4800-01
• Catalog Number: RT-4800-01
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962110966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193243

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: 2020-03-12
• Device Publish Date: 2020-03-04

Devices Manufactured by Qfix

• 00841962120340 - Edge Guide System: 2025-09-19 Lithotomy Edge Guide System
• 00841962119467 - Alpine Stirrups: 2025-07-17 Stirrup, Left
• 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: 2025-07-17 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