Guardian Liner
Guardian Liner 32-6 w/gripgel
1manufacturer
36catalogue 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 | Alps South LLC, United States |
|---|---|
| FDA product code | ISS |
| Device type | Prosthesis, Thigh Socket, External Component |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-12-26 |
| Record revised | 2025-12-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2025-09-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GLBKHD26-6 | Withdrawn | |
| GLAK32-6 | Withdrawn | |
| GLBKHD24-3 | Withdrawn | |
| GLAK26-3 | Withdrawn | |
| GLBK28-3 | Withdrawn | |
| GLBK28-6 | Withdrawn | |
| GLAKHD38-3 | Withdrawn | |
| GLBKHD28-3 | Withdrawn | |
| GLAKHD28-6 | Withdrawn | |
| GLBK16-6 | Withdrawn | |
| GLBK26-6 | Withdrawn | |
| GLBK20-3 | Withdrawn | |
| GLBK20-6 | Withdrawn | |
| GLAKHD32-6 | Withdrawn | |
| GLAKHD32-3 | Withdrawn | |
| GLAK38-3 | Withdrawn | |
| GLBKHD28-6 | Withdrawn | |
| GLAK28-3 | Withdrawn | |
| GLAK28-6 | Withdrawn | |
| GLBKHD24-6 | Withdrawn | |
| GLAK26-6 | Withdrawn | |
| GLAK38-6 | Withdrawn | |
| GLBK26-3 | Withdrawn | |
| GLBKHD20-6 | Withdrawn | |
| GLBK24-3 | Withdrawn | |
| GLBKHD20-3 | Withdrawn | |
| GLBKHD16-6 | Withdrawn | |
| GLAKHD38-6 | Withdrawn | |
| GLAKHD26-3 | Withdrawn | |
| GLBKHD16-3 | Withdrawn | |
| GLAK32-3 | Withdrawn | |
| GLBKHD26-3 | Withdrawn | |
| GLBK16-3 | Withdrawn | |
| GLAKHD28-3 | Withdrawn | |
| GLBK24-6 | Withdrawn | |
| GLAKHD26-6 | Withdrawn |
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.