Symphony Locating Bar, PH Style RT-5100-11PH

GUDID 00841962120395

Symphony Locating Bar, PH Style

Qfix

Indexed-immobilization patient positioning system

• Primary Device ID: 00841962120395
• NIH Device Record Key: 2f032190-1610-4cd0-8882-88bd09b4d501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symphony Locating Bar, PH Style
• Version Model Number: RT-5100-11PH
• Catalog Number: RT-5100-11PH
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841962120395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160627

FDA Product Code

• FRZ: Device, Patient Transfer, 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: 2025-12-10
• Device Publish Date: 2025-12-02

On-Brand Devices [Symphony Locating Bar, PH Style]

• 10841962119464: Symphony Locating Bar, PH Style
• 00841962120395: Symphony Locating Bar, PH Style