Аппараты сшивающие для герниопластики со сменными кассетами: кассеты сменные:

Страна: Беларусь

Язык: русский

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

Доступна с:

Covidien LLC, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Covidien LLC

Дата Авторизация:

2022-11-21

Характеристики продукта

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AbsorbaTack™
Fixation Device with Absorbable Tacks
1075245
EN
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
This booklet is designed to assist in using this product. It is not a
reference to surgical techniques.
This device was designed, tested and manufactured for single patient
use only. Reuse or reprocessing of
this device may lead to its failure and subsequent patient injury.
Reprocessing and/or resterilization of this
device may create the risk of contamination and patient infection. Do
not reuse, reprocess or resterilize
this device.
DESCRIPTION
The AbsorbaTack™ 5 mm device is a sterile, single use device for
fixation of prosthetic material, such as
mesh, to soft tissue. The tack is constructed of an absorbable
synthetic polyester copolymer derived from
lactic and glycolic acid and is dyed with D&C Violet No. 2. The device
is offered with 10, 15, 20 or 30
absorbable tacks with a long shaft and 20 absorbable tacks with a
short shaft.
INDICATIONS
The device is intended for fixation of prosthetic material to soft
tissue in various minimally invasive and
open surgical procedures such as hernia repair.
CONTRAINDICATIONS
1. The device is not intended for use when prosthetic material
fixation is contraindicated.
2. Do not use the AbsorbaTack™ fixation device on tissue(s) which
cannot be inspected visually for
hemostasis.
3. This device should not be used in tissues that have a direct
anatomic relationship to major vascular
stuctures. This would include the deployment of tacks in the diaphragm
in the vicinity of the pericardium,
aorta or inferior vena cava during diaphragmatic hernia repair.
4. Do not use in ischemic or necrotic tissue.
ACTIONS
The tack is made of the common copolymer poly(glycolide-co-L-lactide)
(PGLA). This copolymer
degrades and is absorbed by hydrolysis to glycolic acid and lactic
acid which are then metabolized by
the body.
The absorption profile of poly(glycolide-co-L-lactide) (PGLA) in the
first two weeks after initial
implantation is minim