NON-ABSORBABLE SURGICAL SUTURE
CAUTION: National or local regulations may restrict this device to sale, distribution and use by or on the order of a physician, veterinarian or other licensed practitioner.
Nylon sutures are designed and manufactured in accordance with the European
Council's Directive for Medical Devices MDD93/42/EEC.
Nylon suture consists of the suture thread attached to a suture needle. The suture needle is made of high quality stainless steel specific for medical applications and is firmly attached to the suture thread. Non-absorbable Nylon Suture is a non- absorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6.6. The monofilament polyamide sutures with attached needles are available in black and blue, dyed with FDA listed dye(s). Attached needle types offered include curved and straight needles, with several lengths, gauges,and needle shapes and several suture lengths. Nylon non-absorbable Suture meets all requirements established by the European and United States Pharmacopoeias for non-absorbable polyamide surgical sutures.
Nylon sutures have perfect penetrating capability through the smooth surface of the needle and the seamless attachment to the suture thread whose smooth surface completes the smoothness of the whole suture (thread and needle). It possesses such features as soft thread body and strong tensile strength which make convenient knotting possible.
Tensile strength: Nylon suture's tensile strength exceeds that of the USP standard requirement.
Specification: Nylon sutures are available with or without needle. The needle comes in
used. As any foreign material in the presence of bacterial contamination may enhance the chances of bacterial infection, acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.
Nylon sutures should be stored in a cool dry place with temperature not exceeding
25ºC and humidity below80%. They should not be exposed to direct sunlight.
In handling this or any other suture material, care should be taken to avoid damage from
handling. Avoid crushing or crimping damqge due to application of surgical instruments such as forceps or needle holders. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. As with any suture material, adequate knot security requires the accepted surgical technique of flat square ties, with additional throws made as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments. Discard used needles in "sharps" corttainers and used or left over suture threads in special containers.
Adverse effects associated with the use of this devise include: wound dehiscence, gradual
loss of tensile strength over time, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, enhanced risk of bacterial infection, minimal acute inflammatory tissue reaction, pain, edema and erythema at the wound site. Non-sterilised needle holders can contaminate surgical needles and this can result in the inadvertent transmission of blood borne pathogens.
Inner package: Each suture is packed in an aluminium foil
Box package: 24 pcs/box
Carton package: 50 boxes/carton
different tip shapes such as round bodied, cutting, curved cutting etc. and different body shapes such as straight, half circle, 3/8 circle etc. The suture thread is available in
different diameters and lengths.Biologic Conformity: No stimulation, no hypersusceptibility, no cell toxicity and no genetic toxicity.INDICATIONSNon-absorbable Nylon Sutures are used in operations of general surgery, gynaecology, urology, orthopaedics, ophthalmology, stomatology and other operations.ACTIONSNon-absorbable Nylon Suture elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. While it is not absorbed, progressive bydrolysis of the nylon in-vivo may result in the gradual Ioss of up to20% of its tensile strength per year.CONTRAINDICATIONSDue to the gradual loss of tensile strength which may occur over prolonged period's in-vivo, the Nylon non-absorbable suture should not be used where permanent retention of tensile strength is required, as in fixation of intraocular lenses or synthetic vascular grafts or bone connection.WARNINGSDo not re-sterilise Discard open or damaged packages and unused sutures. Prolonged contact of this or any other suture with salt solutions, such as those found in the urinary of biliary tracts, may result in calculus formation. Users should always choose the appropriate needle for the type of operation to be conducted. Users should be familiar with surgical procedures and techniques involving non- absorbable sutures before employing the non-absorbable suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture materialSymbol Caution consult Accompanying document symbol (instructions for use) 2Non-reusable single use only symbolsterilisation methodSymbol(R=GammaRadiation) Date of manufacture symbol LOT Batch ldentifier Lot NumberSymbol STERILE R 2 Single use only
Catalogue Reference Number Product sterility and
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Sainty International Group Jiangsu Sumex Imp.&Exp.Co.LTD
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