FDA.reportPublic FDA data

Arion Proth-Pro

Primary DI
08717127931583
Brand
Arion Proth-Pro
Company
Arion Holding B.V.
Model
Small
Device description
Donning aid for transfemoral prostheses
Published
2025-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
IPMCover, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717127936656PreviousGS10
08717127931583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717127936656087171279366568717127936656
08717127931583087171279315838717127931583

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
489495862
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717127934409Arion Easy-Slide Made-to-measure2025-02-03
08717127934416Arion MagnideMade-to-measure2025-02-03
08717127934423Arion Sim-Slide Made-to-measure2025-02-03
08717127934430Arion Easy-OffMade-to-measure2025-02-03
08717127934447Arion Easy-Slide ArmMade-to-measure2025-02-03
08717127934454Arion Proth-ProMade-to-measure2025-02-03
08717127941247Arion Easy-OffMade-to-measure2023-11-03
08717127941254Arion Easy-Slide ArmMade-to-measure2023-11-03
08717127941261Arion Easy-Slide Made-to-measure2023-11-03
08717127941278Arion MagnideMade-to-measure2023-11-03
08717127941285Arion Proth-ProMade-to-measure2023-11-03
08717127941292Arion Sim-Slide Made-to-measure2023-11-03
08717127930111Arion Easy-Slide Extra Small2025-01-13
08717127930401Arion Easy-Slide Small2025-01-13
08717127930432Arion Easy-Slide Medium2025-01-13
08717127930463Arion Easy-Slide Large2025-01-13
08717127930494Arion Easy-Slide Extra Large2025-01-13
08717127930555Arion MagnideLarge2025-01-13
08717127930586Arion MagnideExtra Large2025-01-13
08717127930616Arion Magnide 2in1Medium2025-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257044988MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046197MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046203MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046210MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046463MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046470MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046487MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046494MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046500MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046517MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046524MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046531MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046548MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046555MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046562MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046579MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046586MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046593MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046609MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046616MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046623MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046630MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046647MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046654MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046661MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046678MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046685MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046692MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046708MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046715MEDIMEDI MANUFACTURING, INC.IPM2025-10-03