| 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 | 
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 | 
| regulatory@cqmedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00841439115084 [Primary] | 
| IYE | Accelerator, Linear, Medical | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-09-22 | 
| Device Publish Date | 2025-09-12 | 
| 00841439114650 - Pronumbra | 2025-09-22 Pronumbra Helping Hand, Left | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ONEFIT  97829521  not registered Live/Pending | Blanchard Contact Lens, Inc. 2023-03-08 | 
|  ONEFIT  90538916  not registered Live/Pending | Advanced Drainage Systems, Inc. 2021-02-22 | 
|  ONEFIT  90523037  not registered Live/Pending | ARTSANA S.P.A. 2021-02-10 | 
|  ONEFIT  88697252  not registered Live/Pending | OneFit LLC 2019-11-18 | 
|  ONEFIT  88245336  not registered Live/Pending | Shenzhen Teshun International Trading Co., Ltd. 2018-12-30 | 
|  ONEFIT  87384303  not registered Dead/Abandoned | Shenzhen Tesoon International Trade Co., Ltd. 2017-03-24 | 
|  ONEFIT  85523036  4232886 Live/Registered | Blanchard Contact Lenses Inc 2012-01-23 | 
|  ONEFIT  79218832  5461514 Live/Registered | OSSTEMIMPLANT CO., LTD. 2017-09-15 | 
|  ONEFIT  78737676  not registered Dead/Abandoned | Furious Integrated Training Systems, Inc. 2005-10-21 |