Smart Seal Liner
SAFR Casting Liner Kit 3M Size 26, 28, 32, 35
1manufacturer
66catalogue 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 | 2024-12-30 |
| Record revised | 2025-12-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SADT24-6 | In distribution | |
| SBFR20-3 | In distribution | |
| SBFR24-6 | In distribution | |
| CSBFR-6MM | In distribution | |
| SBFR28-3 | In distribution | |
| SAFR38-6 | In distribution | |
| SBFR20-6 | In distribution | |
| SAFR32-3 | In distribution | |
| SADT28-6 | In distribution | |
| SAFR26-6 | In distribution | |
| SAFR28-6 | In distribution | |
| SAFR28-3 | In distribution | |
| SAFR32-6 | In distribution | |
| SADT32-6 | In distribution | |
| SBFR28-6 | In distribution | |
| SADT38-6 | In distribution | |
| SADT26-3 | In distribution | |
| CSADT-6MM | In distribution | |
| CSAFR-3MM | In distribution | |
| SBFR26-6 | In distribution | |
| SADT20-6 | In distribution | |
| SAFR26-3 | In distribution | |
| SADT26-6 | In distribution | |
| SADT24-3 | In distribution | |
| SADT20-3 | In distribution | |
| SAFR35-3 | In distribution | |
| SADT28-3 | In distribution | |
| CSAFR-6MM | In distribution | |
| CSBFR-3MM | In distribution | |
| SADT38-3 | In distribution | |
| SAFR35-6 | In distribution | |
| SADT32-3 | In distribution | |
| SBFR24-3 | In distribution | |
| SAFR38-3 | In distribution | |
| SBFR26-3 | In distribution | |
| CSADT-3MM | In distribution | |
| SADT20-3-C | Withdrawn | |
| SADT26-3-C | Withdrawn | |
| SBFR26-3-C | Withdrawn | |
| SADT38-6-C | Withdrawn | |
| SADT24-6-C | Withdrawn | |
| SAFR32-6-C | Withdrawn | |
| SBFR20-6-C | Withdrawn | |
| SADT38-3-C | Withdrawn | |
| SAFR38-6-C | Withdrawn | |
| SADT28-6-C | Withdrawn | |
| SAFR35-6-C | Withdrawn | |
| SAFR26-6-C | Withdrawn | |
| SAFR38-3-C | Withdrawn | |
| SBFR24-6-C | Withdrawn | |
| SAFR28-6-C | Withdrawn | |
| SAFR35-3-C | Withdrawn | |
| SBFR28-3-C | Withdrawn | |
| SADT20-6-C | Withdrawn | |
| SADT32-3-C | Withdrawn | |
| SADT32-6-C | Withdrawn | |
| SADT28-3-C | Withdrawn | |
| SAFR28-3-C | Withdrawn | |
| SAFR26-3-C | Withdrawn | |
| SAFR32-3-C | Withdrawn | |
| SADT24-3-C | Withdrawn | |
| SBFR26-6-C | Withdrawn | |
| SBFR20-3-C | Withdrawn | |
| SBFR24-3-C | Withdrawn | |
| SADT26-6-C | Withdrawn | |
| SBFR28-6-C | 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 |
| Silicone Liner | Alps South LLC | 52 |
| Easysleeve | Alps South LLC | 43 |
| Wintersgel Liner | Alps South LLC | 42 |
| ECO Liner | Alps South LLC | 36 |
| Guardian 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.