Изделия для рентгенэндоваскулярной хирургии: проводник Traxcess:

Страна: Беларус

Език: руски

Източник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Предлага се от:

MicroVention, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

Клас:

изделия медицинского назначения

Произведено от:

MicroVention

Дата Оторизация:

2023-08-01

Данни за продукта

English
Traxcess™ Docking Wire
Instructions for Use
For Use with the Traxcess™ Guidewire
For further instructions and information,
refer to the Instructions for Use that
accompanies the Traxcess Guidewire.
DEVICE DESCRIPTION
The Traxcess Docking Wire is a 0.014" diameter guidewire attachment
consisting of stainless steel and nitinol. The shaft is coated with
polytetrafluoroethylene (PTFE) for lubricity. The Traxcess Docking
Wire is
compatible with the Traxcess guidewire with an extendable proximal
end.
The Traxcess Docking Wire is used to extend the guidewire for
facilitating
catheter replacement.
CONTENTS
One docking wire.
INDICATIONS FOR USE
The Traxcess Docking Wire is intended for general intravascular use,
including the neuro and peripheral vasculature. The Traxcess Docking
Wire can be used with Traxcess guidewires to facilitate the placement
of
diagnostic or therapeutic catheters. This device is not intended for
use in
coronary arteries.
There are no known contraindications.
CAUTIONS
Rx-Only: Federal law (USA) restricts this device to sale by or on the
order
of a physician.
WARNINGS
The Traxcess Docking Wire should only be used by physicians who are
familiar with angiographic and interventional procedures. It is
important to
follow the instructions for use prior to using this product.
The Traxcess Docking Wire is provided sterile and non-pyrogenic unless
the unit package is opened or damaged. Do not use if package is opened
or damaged.
The Traxcess Docking Wire is intended for single use only. Do not
resterilize
and/or reuse the device. After use, dispose in accordance with
hospital
and/or local government policy. Do not use if the packaging is
breached
or damaged.
Inspect the Traxcess Docking Wire prior to use for any irregularities
or
damage and discard if noted.
The Traxcess Docking Wire cannot be used alone and must be used with
the guidewire securely connected.
Attachment and detachment to and from the guidewire should be done
while confirming the position of the guidewire tip and catheter under
hi