IntegraBite RT-A001

GUDID 00841962119856

IntegraBite Plates

Qfix

Patient positioning thermoplastic mould material

• Primary Device ID: 00841962119856
• NIH Device Record Key: 5686ce66-5e95-473e-874d-7875c32e6cff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntegraBite
• Version Model Number: RT-A001
• Catalog Number: RT-A001
• 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: 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: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841962119856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935067

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: 2025-11-21
• Device Publish Date: 2025-11-13

Devices Manufactured by Qfix

• 00841962119856 - IntegraBite: 2025-11-21IntegraBite Plates
• 00841962119856 - IntegraBite: 2025-11-21 IntegraBite Plates
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• 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