Материал шовный: материал шовный плетеный рассасывающийся Polysorb™ (Polysorb™ Braided Absorbable Suture):

Nchi: Belarusi

Lugha: Kirusi

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

Shusha Tabia za bidhaa (SPC)
31-07-2023

Inapatikana kutoka:

Covidien LLC, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

Darasa:

изделия медицинского назначения

Viwandani na:

Covidien LLC

Idhini ya tarehe:

2023-08-01

Tabia za bidhaa

                                Maxon™ and
Maxon™ CV
Monofilament Absorbable
Suture
PT00105321
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION
THOROUGHLY.
DESCRIPTION
Maxon™ and Maxon™ CV monofilament polyglyconate synthetic
absorbable
sutures are prepared from a copolymer of glycolic acid and
trimethylene
carbonate. Maxon™ and Maxon™ CV synthetic absorbable sutures are
dyed
with D&C Green No. 6 to increase visibility and are also available
clear (undyed).
Maxon™ and Maxon™ CV synthetic absorbable sutures meet all
requirements established by the United States Pharmacopeia (USP) and
the European Pharmacopeia (EP) for synthetic absorbable surgical
sutures,
except for minor variations in suture diameter.
Such variations are:
MAXIMUM SUTURE OVERSIZE IN DIAMETER (MM) FROM USP
AND EP
USP/EP
SIZE
USP SIZE DESIGNATION (MM)
MAXIMUM
OVERAGE (MM)
7-0/0.5
0.050-0.069
0.015
6-0/0.7
0.070-0.099
0.025
5-0/1
0.10-0.149
0.035
4-0/1.5
0.15-0.199
0.040
3-0/2
0.20-0.249
0.055
2-0/3
0.30-0.339
0.055
0/3.5
0.35-0.399
0.070
1/4
0.40-0.499
0.070
INDICATIONS
Maxon™ and Maxon™ CV sutures are indicated for use as absorbable
sutures in general soft tissue approximation and/or ligation, in
pediatric
cardiovascular tissue, where growth is expected to occur, and in
peripheral
vascular tissue.
Maxon™ and Maxon™ CV sutures are not indicated for use in adult
cardiovascular tissue, ophthalmic surgery, microsurgery, and neural
tissue.
ACTIONS
Maxon™ and Maxon™ CV synthetic absorbable sutures elicit a minimal
acute
inflammatory reaction in tissues, which is followed by gradual
encapsulation
of the suture by fibrous connective tissue. Progressive loss of
tensile strength
and eventual absorption of Maxon™ and Maxon™ CV synthetic
absorbable
sutures occurs by means of hydrolysis where the suture is broken down
and
subsequently absorbed and metabolized by the body.
Studies indicate that tensile strength for Maxon™ and Maxon™ CV
sutures
is approximately 80% of the original suture strength at one week post-
implant. Approximately 75% of the origin
                                
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