ContexGel.sleeve
ContexGel.sleeve, sand-coloured, knee sleeve, size XXL, length: 38,5 cm, one-piece knit cover, antibacterial finish
1manufacturer
10catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shaoxing Annor Textile Company Limited | Shaoxing | Zhejiang | Contract manufacturer | 2 |
Record
| Listed by | Streifeneder ortho.production gmbH, Germany |
|---|---|
| FDA product code | ISS |
| Device type | Prosthesis, Thigh Socket, External Component |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-11-03 |
| Record revised | 2020-11-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30L50/M | 30L50/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L10/XXL | 30L10/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L50/XL | 30L50/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L10/XL | 30L10/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L50/XXL | 30L50/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L50/S | 30L50/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L10/M | 30L10/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L10/L | 30L10/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L50/L | 30L50/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
| 30L10/S | 30L10/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Extreme Liner | Alps South LLC | 154 |
| Superior Performance Liner | Alps South LLC | 150 |
| Easyliner | Alps South LLC | 149 |
| Private Label Liner | Alps South LLC | 120 |
| Ultra Seal Liner | Alps South LLC | 114 |
| Silicone PRO Liner | Alps South LLC | 92 |
| General Purpose Liner | Alps South LLC | 77 |
| Smart Seal Liner | Alps South LLC | 66 |
| Silicone Liner | Alps South LLC | 52 |
| Easysleeve | Alps South LLC | 43 |
| Wintersgel Liner | Alps South LLC | 42 |
| ECO Liner | Alps South LLC | 36 |
Showing 12 of 87. All products under Prosthesis, Thigh Socket, External Component
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.