Vista Ankle Hydraulic CA500-HYD

GUDID 00850013242290

Hydraulic ankle for elevated vacuum suspension

CYPRESS ADAPTIVE, LLC

Ankle-disarticulation prosthesis
Primary Device ID00850013242290
NIH Device Record Key39e3d10b-645b-4366-8f4f-837baed75647
Commercial Distribution StatusIn Commercial Distribution
Brand NameVista Ankle Hydraulic
Version Model NumberCA500-HYD
Catalog NumberCA500-HYD
Company DUNS080277500
Company NameCYPRESS ADAPTIVE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013242290 [Primary]

FDA Product Code

ISYJoint, Knee, External Limb Component

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-10
Device Publish Date2019-12-02

Devices Manufactured by CYPRESS ADAPTIVE, LLC

00850013242894 - Aria Universal Mini Valve Molding Dummy2023-10-13 Molding dummy is used to install the Aria Universal Mini Valve in a prosthesis socket
00850013242887 - Aria Universal Mini Valve Key2022-10-10 Tool to install or remove valves for prosthesis sockets
00850013242016 - Aria Mini Valve2021-11-25 Valve for installation into limb prosthesis with a small diameter and low profile.
00085001342106 - Aria Mini Valve2021-08-19 Valve for installation into limb prosthesis with a small diameter and low profile.
00850013242009 - Aria Valve (US)2019-12-25 Auto Expulsion suction valve (US threads) for prosthetic sockets
00850013242023 - Aria valve (metric)2019-12-25 Aria valve (metric threads) auto expulsion suction valve for prosthetic sockets.
00850013242030 - Aria Valve Plus (US)2019-12-25 Aria valve plus auto-expulsion valve for installation in lower-limb prosthesis sockets for suction suspension.
00850013242047 - Aria valve plus (metric)2019-12-25 Aria valve (metric) auto expulsion suction valve for prosthetic sockets.

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