FDA.reportPublic FDA data

SUPERIOR PERFORMANCE SLEEVE

Primary DI
00713980009252
Brand
SUPERIOR PERFORMANCE SLEEVE
Company
Alps South, LLC
Model
SFPHD28-6
Device description
HD Superior Performance Sleeve
Published
2024-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00713980009252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00713980009252007139800092527139800092520713980009252

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00713980038023ULTRA SEAL LINERUSUGC20-32025-07-03
00713980038030ULTRA SEAL LINERUSUGC24-32025-07-03
00713980038047ULTRA SEAL LINERUSUGC26-32025-07-03
00713980038054ULTRA SEAL LINERUSUGC28-32025-07-03
00713980038061ULTRA SEAL LINERUSUGC32-32025-07-03
00713980038078ULTRA SEAL LINERUSUGC35-32025-07-03
00713980038085ULTRA SEAL LINERUSUGC38-32025-07-03
00713980038092ULTRA SEAL LINERUSUGC44-32025-07-03
00713980038108ULTRA SEAL LINERUSUGL20-32025-07-03
00713980038115ULTRA SEAL LINERUSUGL24-32025-07-03
00713980038122ULTRA SEAL LINERUSUGL26-32025-07-03
00713980038139ULTRA SEAL LINERUSUGL28-32025-07-03
00713980038146ULTRA SEAL LINERUSUGL32-32025-07-03
00713980038153ULTRA SEAL LINERUSUGL35-32025-07-03
00713980038160ULTRA SEAL LINERUSUGL38-32025-07-03
00713980038177ULTRA SEAL LINERUSUGL44-32025-07-03
00713980038184ULTRA SEAL LINERUSUSC202025-07-03
00713980038191ULTRA SEAL LINERUSUSC222025-07-03
00713980038207ULTRA SEAL LINERUSUSC242025-07-03
00713980038214ULTRA SEAL LINERUSUSC262025-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00713980038269ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038276ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038283ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038290ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038306ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038313ULTRA SEAL LINERAlps South, LLCISS2025-07-03