FDA.reportPublic FDA data

Aria Universal Mini Valve Key

Primary DI
00850013242887
Brand
Aria Universal Mini Valve Key
Company
CYPRESS ADAPTIVE, LLC
Model
CA100-MVK
Device description
Tool to install or remove valves for prosthesis sockets
Published
2022-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISPValve, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISPValve, ProsthesisPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013242887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013242887008500132428878500132428870850013242887

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
00850013242894Aria Universal Mini Valve Molding DummyCA100-MVDCA100-MVD2023-10-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194711300006LimbLogicWillowwood Global LLCISP2025-03-21
00194711300013LimbLogicWillowwood Global LLCISP2025-03-21
00194711300082LimbLogicWillowwood Global LLCISP2025-03-21
00194711300099LimbLogicWillowwood Global LLCISP2025-03-21
00194711300105LimbLogicWillowwood Global LLCISP2025-03-21
00194711300112LimbLogicWillowwood Global LLCISP2025-03-21
00194711300129LimbLogicWillowwood Global LLCISP2025-03-21
00194711300136LimbLogicWillowwood Global LLCISP2025-03-21
00194711300143LimbLogicWillowwood Global LLCISP2025-03-21
00194711300150LimbLogicWillowwood Global LLCISP2025-03-21
00194711300167LimbLogicWillowwood Global LLCISP2025-03-21
00194711300174LimbLogicWillowwood Global LLCISP2025-03-21
00194711300181LimbLogicWillowwood Global LLCISP2025-03-21
00194711300198LimbLogicWillowwood Global LLCISP2025-03-21
00194711300204LimbLogicWillowwood Global LLCISP2025-03-21
00194711300211LimbLogicWillowwood Global LLCISP2025-03-21
00194711300228LimbLogicWillowwood Global LLCISP2025-03-21
00194711300235LimbLogicWillowwood Global LLCISP2025-03-21
00194711300242LimbLogicWillowwood Global LLCISP2025-03-21
00194711300259LimbLogicWillowwood Global LLCISP2025-03-21
00194711300266LimbLogicWillowwood Global LLCISP2025-03-21
00194711300273LimbLogicWillowwood Global LLCISP2025-03-21
00194711300280LimbLogicWillowwood Global LLCISP2025-03-21
00194711300297LimbLogicWillowwood Global LLCISP2025-03-21
00194711300303LimbLogicWillowwood Global LLCISP2025-03-21
00194711300310LimbLogicWillowwood Global LLCISP2025-03-21
00194711300334LimbLogicWillowwood Global LLCISP2025-03-21
00194711300341LimbLogicWillowwood Global LLCISP2025-03-21
00194711300358LimbLogicWillowwood Global LLCISP2025-03-21
00194711300365LimbLogicWillowwood Global LLCISP2025-03-21