DeRoyal
Full Length Kodel
5manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Hebei (1), Tianjin (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Alphay Medical Device Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Hengshui Jingkang Medical Device Co., Ltd. | Hengshui | Hebei | Manufacturer | 31 |
| Auckland Medical Polymer (Tianjin) Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 6 |
| Dongguan ZHI QI Handbag Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
| Optima Healthcare Inc. (GD) | Dongguan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | ILZ |
| Device type | Accessories, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5925 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9211-25 | In distribution | |
| 9212-00 | In distribution | |
| 9213-02 | In distribution | |
| 9211-01 | In distribution | |
| 9211-04 | In distribution | |
| 9211-03 | In distribution | |
| 9211-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ISI | Instrument Specialists, Inc. | 70 |
| Bioseal Inc. | Bioseal | 7 |
| Chattanooga | DJO, LLC | 4 |
| EVERYWAY4ALL | Everyway Medical Instruments Co., Ltd. | 4 |
| Convoluted (Eggcrate) Bed Overlay Pad | Primo Medical Group, Inc | 3 |
| iTrac | Pivotal Health Solutions | 2 |
| Traction Adapter | Hill-ROM, Inc. | 2 |
| Rolko | Rolko Kohlgrüber GmbH | 1 |
| Economy Foam Heel Protector | Primo Medical Group, Inc | 1 |
| Buck’s Traction with Foot Position & Heel Hole | Primo Medical Group, Inc | 1 |
| Buck’s Traction with Heel Hole | Primo Medical Group, Inc | 1 |
| Shoulder Traction | Primo Medical Group, Inc | 1 |
Showing 12 of 17. All products under Accessories, Traction
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.