FDA.reportPublic FDA data

SILICONE SLEEVE

Primary DI
00713980001621
Brand
SILICONE SLEEVE
Company
Alps South, LLC
Model
SL-M
Device description
Silicone Suspension Sleeve
Published
2024-12-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISSProsthesis, Thigh Socket, External Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISSProsthesis, Thigh Socket, External ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00713980001621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00713980001621007139800016217139800016210713980001621

GMDN Terms#

Term, Definition table
TermDefinition
External lower-limb prosthesis suspensory component, non-poweredA non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap, sleeve, cuff, thigh corset, shell, belt, pin, lock, valves).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824697569
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00713980005377VELCRO LINERJWFR44-62024-12-26
00713980001614SILICONE SLEEVESL-L2024-12-30
00713980001638SILICONE SLEEVESL-S2024-12-30
00713980001645SILICONE SLEEVESL-XL2024-12-30
00713980001652SILICONE SLEEVESL-XXL2024-12-30
00713980001669SILICONE SLEEVESLR-2XL2024-12-30
00713980001676SILICONE SLEEVESLR-2XL-BL2024-12-30
00713980001683SILICONE SLEEVESLR-2XL-N2024-12-30
00713980001690SILICONE SLEEVESLR-3XL2024-12-30
00713980001706SILICONE SLEEVESLR-3XL-BL2024-12-30
00713980001713SILICONE SLEEVESLR-3XL-N2024-12-30
00713980001720SILICONE SLEEVESLR-4XL2024-12-30
00713980001737SILICONE SLEEVESLR-4XL-BL2024-12-30
00713980001744SILICONE SLEEVESLR-4XL-N2024-12-30
00713980001751SILICONE SLEEVESLR-5XL2024-12-30
00713980001768SILICONE SLEEVESLR-5XL-BL2024-12-30
00713980001775SILICONE SLEEVESLR-5XL-N2024-12-30
00713980001782SILICONE SLEEVESLR-L2024-12-30
00713980001799SILICONE SLEEVESLR-L-BL2024-12-30
00713980001805SILICONE SLEEVESLR-L-N2024-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650532Lumo Socket A-1macu4 GmbHISS2026-07-18
04262429650549Lumo Socket A-2macu4 GmbHISS2026-07-18
04262429650556Lumo Socket A-3macu4 GmbHISS2026-07-18
04262429650624Lumo Socket A-4macu4 GmbHISS2026-07-18
04262429650631Lumo Socket B-1macu4 GmbHISS2026-07-18
04262429650891Lumo Socket B-2macu4 GmbHISS2026-07-18
04262429650907Lumo Socket B-3macu4 GmbHISS2026-07-18
04262429650914Lumo Socket B-4macu4 GmbHISS2026-07-18
04262429650921Lumo Socket C-1macu4 GmbHISS2026-07-18
04262429650938Lumo Socket C-2macu4 GmbHISS2026-07-18
04262429650945Lumo Socket C-3macu4 GmbHISS2026-07-18
04262429650952Lumo Socket C-4macu4 GmbHISS2026-07-18
04262429650969Lumo Socket D-1macu4 GmbHISS2026-07-18
04262429650976Lumo Socket D-2macu4 GmbHISS2026-07-18
04262429650983Lumo Socket D-3macu4 GmbHISS2026-07-18
04262429650990Lumo Socket D-4macu4 GmbHISS2026-07-18
04262429651003Lumo Socket E-1macu4 GmbHISS2026-07-18
04262429651010Lumo Socket E-2macu4 GmbHISS2026-07-18
04262429651027Lumo Socket E-3macu4 GmbHISS2026-07-18
04262429651034Lumo Socket F-1macu4 GmbHISS2026-07-18
04262429651041Lumo Socket F-2macu4 GmbHISS2026-07-18
04262429651058Lumo Socket F-3macu4 GmbHISS2026-07-18
04262429651065Lumo Socket F-4macu4 GmbHISS2026-07-18
04262429651072Lumo Socket E-4macu4 GmbHISS2026-07-18
04262429650563Lumo Spacer, STD-Amacu4 GmbHISS2025-11-23
04262429650648Lumo Module Connectormacu4 GmbHISS2025-11-23
04262429650655Lumo Spacer, STD-Bmacu4 GmbHISS2025-11-23
04262429650662Lumo Spacer, STD-Cmacu4 GmbHISS2025-11-23
04262429650679Lumo Spacer, STD-Dmacu4 GmbHISS2025-11-23
04262429650686Lumo Spacer, STD-Emacu4 GmbHISS2025-11-23