ONEFit RT-4800-C0

GUDID 00841439115084

ONEFit Indexing Device

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439115084
• NIH Device Record Key: fc290adc-be13-4452-9353-a471a37b8f6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONEFit
• Version Model Number: RT-4800-C0
• Catalog Number: RT-4800-C0
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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: +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
• 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	00841439115084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153026

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: 2025-09-22
• Device Publish Date: 2025-09-12

Devices Manufactured by MEDTEC, INC.

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• 00841439114674 - Pronumbra: 2025-09-22 Pronumbra Helping Hand, Right
• 00841439114681 - Pronumbra: 2025-09-22 Pronumbra 130cm kVue
• 00841439114698 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 40mm
• 00841439114704 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 50mm
• 00841439114711 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 65mm
• 00841439114728 - Pronumbra: 2025-09-22 Pronumbra Shoulder Adapter
• 00841439114841 - ZiFix Traverse: 2025-09-22 ZiFix Traverse with ONEClamp