Duragel Pin Liner, Uniform, 3mm, Medium+
2 catalogue numbers from 18212, listed by Silipos Holding LLC, United States, under Device, Prosthesis Alignment. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (2), Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Baoji Shengtaike Industry & Trade Co., Ltd. | Baoji | Shanxi | Contract manufacturer | 7 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Huae Trade Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 10 |
| T&L (Jiaxing) Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 4 |
| Fujian Guozi Rehabilitation Medical Co., Ltd. | Fuzhou | Fujian | Manufacturer | 2 |
Record
| Listed by | Silipos Holding LLC, United States |
|---|---|
| FDA product code | IQO |
| Device type | Device, Prosthesis Alignment |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18212 | In distribution | |
| 18211 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoskeletal Components | College Park Industries | 102 |
| Juzo SoftCompress | Julius Zorn, Inc. | 19 |
| Osseointegration Prosthetic Limb | Osseointegration International Pty Ltd | 13 |
| C100 Cylindrical Shuttle Lock | College Park Industries | 13 |
| Juzo Night | Julius Zorn, Inc. | 12 |
| Torsion Adapter | College Park Industries | 6 |
| LA Liner, Pin, Tapered, 9mm, Medium | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 6mm, Large | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 9mm, Medium | Silipos Holding LLC | 2 |
| LA Liner, Pin, Uniform, 3mm, Large+ | Silipos Holding LLC | 2 |
| LA Liner, Pin, Tapered, 3mm, Medium+ | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Tapered, 3mm, Medium+ | Silipos Holding LLC | 2 |
Showing 12 of 38. All products under Device, Prosthesis Alignment
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.