FDA.reportPublic FDA data

Aria Universal Mini Valve Molding Dummy

Primary DI
00850013242894
Brand
Aria Universal Mini Valve Molding Dummy
Company
CYPRESS ADAPTIVE, LLC
Model
CA100-MVD
Catalog number
CA100-MVD
Device description
Molding dummy is used to install the Aria Universal Mini Valve in a prosthesis socket
Published
2023-10-05
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ISPValve, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISPValve, ProsthesisPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013242894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013242894008500132428948500132428940850013242894

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
080277500
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013242092Aria safety barb (US)CA300-ASBCA300-ASB2019-12-17
00850013242108Aria Safety Barb (metric)CA300-ASBMCA300-ASBM2019-12-17
00850013242887Aria Universal Mini Valve KeyCA100-MVK2022-10-01
00850013242016Aria Mini ValveCA100-MVCA100-MV2021-08-11
00085001342106Aria Mini ValveCA100-MVCA100-MV2021-08-11
00850013242009Aria Valve (US)CA200-AVCA200-AV2019-12-17
00850013242023Aria valve (metric)CA200-AVMCA200-AVM2019-12-17
00850013242030Aria Valve Plus (US)CA200-AVPCA200-AVP2019-12-17
00850013242047Aria valve plus (metric)CA200AVPMCA200AVPM2019-12-17
00850013242054Aria E-valveCA200-AECA200-AE2019-12-17
00850013242061Aria plate valveCA300-APVCA300-APV2019-12-17
00850013242078Aria HV Plate Valve CA300-AHVPCA300-AHVP2019-12-17
00850013242085Aria Hybrid ValveCA300-HYVCA300-HYV2019-12-17
00850013242115Aria AK ValveCA100-AKCA100-AK2019-12-17
00850013242122Aria AK valve insertCA100-VICA100-VI2019-12-17
00850013242139Cypress 4-hole tie-in plateCA400-TIPCA400-TIP2019-12-17
00850013242146Cypress low profile 4-hole tie-in plateCA400-LPCA400-LP2019-12-17
00850013242153Aria auto expulsion valve insertCA400-VCA400-V2019-12-17
00850013242160Aria HV Valve insert CA400-HVCA400-HV2019-12-17
00850013242177Aria 90 degree HV Valve Insert CA400-HV9CA400-HV92019-12-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00194711300334LimbLogicWillowwood Global LLCISP2025-03-21
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