FDA.reportPublic FDA data

ULTRA SEAL LINER

Primary DI
00713980035039
Brand
ULTRA SEAL LINER
Company
Alps South, LLC
Model
USHSC41
Device description
Ultra Seal High Ring Cushion Liner Size 41
Published
2024-12-27
Public version status
New
Distribution status
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
00713980035039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00713980035039007139800350397139800350390713980035039

GMDN Terms#

Term, Definition table
TermDefinition
External limb prosthesis socket linerA flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).

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
00713980001621SILICONE SLEEVESL-M2024-12-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00713980038023ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038030ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038047ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038054ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038061ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038078ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038085ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038092ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038108ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038115ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038122ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038139ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038146ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038153ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038160ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038177ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038184ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038191ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038207ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038214ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038221ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038238ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038245ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038252ULTRA SEAL LINERAlps South, LLCISS2025-07-03