Juzo Night
Juzo Night, Regular, Right , 3
6manufacturers in China registered for this device type
12catalogue 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 | Julius Zorn, Inc., 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 | 2023-09-08 |
| Record revised | 2024-12-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6872ACGRLE 3 | In distribution | |
| 6872ACGLRI 4 | In distribution | |
| 6872ACGLRI 3 | In distribution | |
| 6872ACGLRI 2 | In distribution | |
| 6872ACGLLE 4 | In distribution | |
| 6872ACGRRI 3 | In distribution | |
| 6872ACGLLE 2 | In distribution | |
| 6872ACGRLE 4 | In distribution | |
| 6872ACGRRI 4 | In distribution | |
| 6872ACGRLE 2 | In distribution | |
| 6872ACGRRI 2 | In distribution | |
| 6872ACGLLE 3 | 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 |
| 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, 3mm, Medium+ | 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.