FDA.reportPublic FDA data

SKIN RELIEVER

Primary DI
00713980001515
Brand
SKIN RELIEVER
Company
Alps South, LLC
Model
ENCP16
Device description
Skin Reliever-Gel Sheath 3mm
Published
2024-11-01
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
00713980001515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00713980001515007139800015157139800015150713980001515

GMDN Terms#

Term, Definition table
TermDefinition
Stump sockA sleeve designed to be worn over a residual limb to improve contact between the stump and the socket interface of an external limb prosthesis/orthosis to: 1) provide a cushion for the alleviation of friction; 2) enable a more comfortable and stable use of the prosthesis/orthosis; and 3) function as an aid in the daily fitting of the prosthesis by an amputee patient. It is typically made of textile materials (e.g., wool, cotton). This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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