Изделия для урологии и нефростомии: катетер для нефростомии Percuflex Locking Loop / Percuflex™ Locking Loop Nephrostomy Catheter,

Страна: Беларусь

Язык: русский

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

Доступна с:

Boston Scientific Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Boston Scientific Corporation

Дата Авторизация:

2020-05-28

Характеристики продукта

50502703-01
INSTRUCCIONES DE USO
6
MODE D’EMPLOI
10
GEBRAUCHSANWEISUNG
14
ISTRUZIONI PER L’USO
18
GEBRUIKSAANWIJZING
22
INSTRUÇÕES DE UTILIZAÇÃO
26
Boston Scientific (DFU Template 3in x 9in Global, 91031819AA), DFU,
MB, Contour VL, Global, 50502703-01B
Black (K) ∆E ≤5.0
DIRECTIONS FOR USE
2
2019-10
CONTOUR VL
™
Variable Length Percuflex
™
Stent with HydroPlus
™
Coating
2
Boston Scientific (DFU Template 3in x 9in Global, 91031819AA), DFU,
MB, Contour VL, Global, 50502703-01B
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 Contour Variable Length Stent is designed to be placed over a
guidewire to help drain urine from the kidney into the bladder. The
coils on both distal and proximal pigtails allow one stent to be used
in
adult ureters of various lengths. This device is coated with exclusive
HydroPlus
Hydrophilic
coating
which,
when
activated,
significantly
increases the lubricous characteristics of the device. Care should be
exercised when handling this coated device (See “Prior to
Placement”
and “Activate Coating”).
C