Pajjiż: Bjelorussja
Lingwa: Russu
Sors: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Covidien LLC, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Covidien LLC
2023-08-01
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 Aqra d-dokument sħiħ