Изделия для рентгенэндоваскулярной хирургии:

Država: Belorusija

Jezik: ruščina

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

Dostopno od:

Boston Scientific Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

Razred:

изделия медицинского назначения

Izdeluje:

Boston Scientific Corporation

Datum dovoljenje:

2020-12-22

Lastnosti izdelka

INSTRUCCIONES DE USO
4
MODE D’EMPLOI
6
GEBRAUCHSANWEISUNG
8
ISTRUZIONI PER L’USO
10
GEBRUIKSAANWIJZING
12
INSTRUÇÕES DE UTILIZAÇÃO
14
Boston Scientific (Master Brand DFU Template 8in x 8in Global,
90106041AS), DFU, MB, Stingray Guidewire, Global, 50948851-01A
Black (K) ∆E ≤5.0
STINGRAY
™
Guidewire with Hydrophilic Coating
DIRECTIONS FOR USE
2
2
Boston Scientific (Master Brand DFU Template 8in x 8in Global,
90106041AS), DFU, MB, Stingray Guidewire, Global, 50948851-01A
Black (K) ∆E ≤5.0
Black (K) ∆E ≤5.0
ONLY
CAUTION: Federal Law (USA) restricts this device to sale by or on the
order of
a physician.
WARNING
Contents supplied STERILE using an ethylene oxide (EO) process. Do not
use if sterile
barrier is damaged. If damage is found, call your Boston Scientific
representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse,
reprocessing
or resterilization may compromise the structural integrity of the
device and/or
lead to device failure which, in turn, may result in patient injury,
illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of
the device and/or cause patient infection or cross-infection,
including, but not
limited to, the transmission of infectious disease(s) from one patient
to another.
Contamination of the device may lead to injury, illness or death of
the patient.
After
use,
dispose
of
product
and
packaging
in
accordance
with
hospital,
administrative and/or local government policy.
DEVICE DESCRIPTION
The Stingray Guidewires are available in a nominal diameter of 0.014
in (0.36 mm)
and a nominal length of 185 cm or 300 cm. In general, the Stingray
Guidewires
have a coiled distal end where the coil is radiopaque to facilitate
advancement
into and withdrawal from the vasculature using fluoroscopy. The
proximal shaft is
coated with polytetrafluoroethylene (PTFE) while the distal shaft in
the region of
the coil is coated with hydrophilic coating. The narrowed distal tip
is intended to
aid in guidewire control. Refer to the