Silicone Liner

26 CM Clear Gen Thick

Registry build 21.09.26
1manufacturer
52catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ISS
Manufacturer City Province Registered as Device types
Shaoxing Annor Textile Company Limited Shaoxing Zhejiang Contract manufacturer 2

Record

Regulatory record for Silicone Liner
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 2024-12-27
Record revised 2025-12-17 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number
Distribution end date 2025-01-06

Catalogue Numbers

Catalogue numbers for Silicone Liner
Catalogue number Size Status
SSA20-3.0 Withdrawn
SSA44-3.0 Withdrawn
SSA28-3.0 Withdrawn
GL-14 Withdrawn
SSA20-1.5 Withdrawn
GL-26-T Withdrawn
GL-22-T Withdrawn
GL-28-T Withdrawn
GL-18-T Withdrawn
SSA16-3.0 Withdrawn
GL-24-T Withdrawn
SSA26-1.5 Withdrawn
GL-20-T Withdrawn
SSA38-3.0 Withdrawn
SSA18-3.0 Withdrawn
SSA18-1.5 Withdrawn
SSA30-3.0 Withdrawn
GL-16 Withdrawn
GL-32 Withdrawn
SSA44-1.5 Withdrawn
GL-20 Withdrawn
GL-32-T Withdrawn
SSA24-1.5 Withdrawn
GL-44 Withdrawn
GL-38 Withdrawn
GL-14-T Withdrawn
GL-24 Withdrawn
SSA34-3.0 Withdrawn
SSA34-1.5 Withdrawn
GL-30 Withdrawn
SSA16-1.5 Withdrawn
SSA38-1.5 Withdrawn
GL-16-T Withdrawn
GL-34 Withdrawn
GL-26 Withdrawn
SSA26-3.0 Withdrawn
GL-28 Withdrawn
GL-30-T Withdrawn
SSA32-3.0 Withdrawn
SSA24-3.0 Withdrawn
SSA14-1.5 Withdrawn
SSA32-1.5 Withdrawn
SSA28-1.5 Withdrawn
SSA14-3.0 Withdrawn
GL-22 Withdrawn
GL-44-T Withdrawn
SSA30-1.5 Withdrawn
SSA22-3.0 Withdrawn
GL-18 Withdrawn
SSA22-1.5 Withdrawn
GL-38-T Withdrawn
GL-34-T Withdrawn

Same Product Code

Other products under the same FDA 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
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer