Изделия для урологии и нефростомии с принадлежностями: система трансобтураторная Obtryx™ II для лечения недержания мочи с дизайном PrecisionBlue / Obtryx™ II System Transobturator Sling with PrecisionBlue Design:

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:

2020-11-11

Характеристики продукта

50502707-01
INSTRUCCIONES DE USO
6
MODE D’EMPLOI
10
GEBRAUCHSANWEISUNG
14
ISTRUZIONI PER L’USO
18
GEBRUIKSAANWIJZING
22
INSTRUÇÕES DE UTILIZAÇÃO
26
Boston Scientific (Master Brand DFU Template 3in x 9in Global,
90106040 AS), DFU, MB, Contour VL SureDrive Steerable Stent Set,
Global, 50502707-01B
Black (K) ∆E ≤5.0
DIRECTIONS FOR USE
2
2019-10
CONTOUR VL
™
SUREDRIVE
™
Steerable Ureteral Stent Set
2
Boston Scientific (Master Brand DFU Template 3in x 9in Global,
90106040 AS), DFU, MB, Contour VL SureDrive Steerable Stent Set,
Global, 50502707-01B
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