POLYGLACTIN
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.
STERILIZATION
Ethylene Oxide.
DESCRIPTION
Polyglactin sutures are designed and manufactured in accordance with the European Council's
Directive for Medical Devices MDD93/42/EEC.
Polyglactin 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. The suture (needle and thread) is used to suture soft tissue ón the human body. Polyglactin is a synthetic absorbable multifiliment sterile surgical suture composed of glycolic (90%) and L- Lactide (10%) forming a copolymer. The Polyglactin suture yarns are braided and coated with calcium sterate and Polyglactin 370. The suture thread and coating can be absorbed by the human body through hydrolysis which has no adverse effect on the human body. Polyglactin sutures fulfil all the requirements of USP and European Pharmacopoeia for sterile,synthetic absorbable sutures.
Polyglactin sutures have perfect penetrating capability through the smooth surface of the needle and the seamless attachment to the suture thread whose coating completes the smocthness 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: All of the original tensile strength is lost between four and five weeks post implantation. Spacification: Polyglactin sutures are available with or without needle. The needle comes in 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 can be dyed purple or with different diameters and lengths.
INDICATIONS
Polyglactin suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures but not for use in cardiovascular and neurological tissues.
ACTIONS
Polyglactin suture elicits a minimal acute inflammatory reaction in tissue and in growth of fibrous connective tissue. All of the original tensile strength is lost between four to five weeks post implantation. Absorption of the Polyglactine suture is completed by hydrolysis and metabolised by the body as the copolymer degrades to glycolic and lactic acids. Absorption of Polyglactine suture is essentially
STORAGE CONDITIONS
Polyglactin sutures should be stored in a cool dry place with temperature not exceeding 25ºC and humidity
below 80%. They should not be exposed to direct sunlight.
PRECAUTIONS
Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be
snipped off or removed as indicated. Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon. Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur.
In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Polyglactine sutures, which are treated to enhance handling characteristics, require the acceptde surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.
Avoid prolonged exposure to elevated temperatures. To avoid damage to the needle points and swage areas grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avold inadvertent needle sticks. Discard used needles in "sharps" containers and used or left over suture threads in special containers.
ADVERSE REACTIONS
Adverse effects associated with the use of this suture include wound dehiscence, failure to provide adequate
wound support in closure of the sites where expansion, stretching, or distension occurs , failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infecticn, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. lnadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens.
PACKAGE SPECIFICATION
Inner package: Each suture is packed in an aluminium foil
Box package: 24 pcs/box
Carton package: 50 boxes/carton
LABELLING SPECIFICATION
complete between 56 - 70 days.
REF
STERILE EO
CONTRAINDICATIONS
Catalogue Reference Product sterility and
This suture, being absorbable, should not be used where extended approximation of tissue is required. lt
Number Symbol
sterilisation method Symbol
Date of expiration
should not be used in tissues where high tensile strength is required for long periods or in cardiovascular and neurological tissues.
WARNINGS
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 absorbable sutures before employing Polyglactine suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Physicians should consider the in vivo performance (under ACTIONS section) when selecting a suture. The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing. As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention, or which may require abbitional support.
Do not re-sterilise. Discard opened or damaged packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions may result in calculus formation; such as those found in the urinary or biliary tracts. As an absorbable suture, the coated Polyglactin suture may act transiently as a
Caution consult Accompanying document symbol (instructions for use)
2
Non-reusable single use only symbol
(EO=Ethylene Oxide)
Date of manufacture symbol
LOT
Batch ldentifier Lot
Number Symbol
symbol
25ºC
Upper Limit of Temperature Symbol (Limit is 25ºC)
foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
STERILE EO
2 Single use only
Company informayion :
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Company Name
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Sainty International Group Jiangsu Sumex Imp.&Exp.Co.LTD
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Contact Person
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dong fang Yin (Your message will be sent to the supplier directly)
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Address
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8F,Foreign Trade Building,,No.18 West Wengchang Road,YangZhou,Jiangsu,China
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Telephone
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86-514-85168444
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Fax
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86-514-85168445
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Why choose us :
Product packing :
FAQ :
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