Bioseal Inc.
Traction Rope w/ S Hook
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 | Bioseal, United States |
|---|---|
| FDA product code | ILZ |
| Device type | Accessories, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5925 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-13 |
| Record revised | 2026-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 25, case |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16360/25 | In distribution | |
| 16366/25 | In distribution | |
| 16372/25 | In distribution | |
| 16364/25 | In distribution | |
| 16363/25 | In distribution | |
| 17147/01 | In distribution | |
| 16365/25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ISI | Instrument Specialists, Inc. | 70 |
| DeRoyal | Deroyal Industries, Inc. | 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.