FDA.report

Skinergy Plus

Primary DI
05055348232878
Brand
Skinergy Plus
Company
HUGH STEEPER LIMITED
Model
Closed Toe TrueFinish™ Skinergy Plus 22/23 Left L
Catalog number
TNS22LL/E5
Published
2023-07-18
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

Related Records

Product Codes

CodeName
IPMCover, Limb

Product Code Classifications

CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055348232878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055348232878050553482328785055348232878

GMDN Terms

TermDefinition
External limb prosthesis finishing component, non-customizedA prefabricated cosmetic component of an external upper or lower limb prosthesis designed to provide an aesthetic outer shape and surface to the prosthesis via one of various forms (e.g., foot shell, filler, skin, stocking, glove, limb cover) ready to be assembled, fitted, and adjusted to the patient. It may be made of various materials (e.g., foam, thermoplast, wood, silicone, fibreglass, resin, carbon fibre), and may additionally be designed to protect the prosthesis from external agents (e.g., debris, water splashes, impact forces).

Sterilization Methods

Method

Regulatory Flags

DUNS number
210280350
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
05063368529106BATTERY SYSTEMLITHIUM BATTERY CHARGERLIBCH2023-10-04
05063368529502BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05063368529496BATTERY SYSTEM45MM KINISI SH WR HOUSINGMKSW452023-10-04
05063368529519BATTERY SYSTEM50MM KINISI SH WR HOUSING M12BBSW50-M122023-10-04
05063368529526Wrist45MM STEEPER FR HD PL KITSFW0452023-10-04
50633685291064BATTERY SYSTEMLITHIUM BATTERY CHARGERLIBCH2023-10-04
50633685295024BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05055348200228S-CHARGES-Charger - Wall Charger KitSWC22002023-08-08
05055348248602PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG20/E22023-08-08
05055348249784PVC GloveTrueFinish ™ PVC Glove Male HD Number# Colour# TG104/E62023-08-08
05055348252708PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E82023-08-08
05056349561615PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E32023-08-08
05056349561622PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E52023-08-08
05056349561639PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E72023-08-08
05056349561646PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E92023-08-08
05056349563251PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG19/E32023-08-08
05056349563428PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG2/E32023-08-08
05056349563473PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG20/E12023-08-08
05056349563725PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG200/E22023-08-08
05056349563923PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG201/E32023-08-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20809160489885Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-08-01
20809160489465Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-07-31
08717127934409Arion Easy-Slide Arion Holding B.V.IPM2025-02-03
08717127934416Arion MagnideArion Holding B.V.IPM2025-02-03
08717127934423Arion Sim-Slide Arion Holding B.V.IPM2025-02-03
08717127934430Arion Easy-OffArion Holding B.V.IPM2025-02-03
08717127934447Arion Easy-Slide ArmArion Holding B.V.IPM2025-02-03
08717127934454Arion Proth-ProArion Holding B.V.IPM2025-02-03
08717127930111Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930401Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930432Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930463Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930494Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930555Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930586Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930616Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930647Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930678Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930708Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930739Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930760Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930791Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930821Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930852Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930883Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930913Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930944Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930975Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931002Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931040Arion SlideXArion Holding B.V.IPM2025-01-13