PRIMA Polyglycolic Acid Surgical Suture 75cm Tapercut Needle 3/8 16mm USP 3/0

In stock
Product code 1840-TT3/8-16-3/0
€21.38 €17.97
Improve your surgical interventions with PRIMA polyglycolic acid surgical suture featuring a violet thread, boasting a length of 75cm and equipped with a Tapercut needle (with sharp triangular tip and continuous round body) 3/8 circle with a length of 16mm and a diameter of USP 3/0, available in packages of 12 pieces. This high-quality product is designed to meet your surgical needs efficiently and safely. Suture dimensions are typically indicated using the USP (United States Pharmacopeia) system. This numbering system can be a bit confusing but revolves around the suture "0". Suture sizes increase from USP size 0 ("zero") to size 1, commonly referred to as "number 1", to USP size 2 ("number 2") and above. Polyglycolic acid suture (polyglycolic acid) is a sterile, synthetic, braided absorbable surgical suture prepared from 100% glycolide homopolymers. The POLYGLYCOLIC ACID suture is colored with D&C Violet No. 2 (in accordance with US Federal Regulations). The POLYGLYCOLIC ACID suture is also available in an uncolored form. For additional lubrication, smooth tissue passage, and easy knot tying, POLYGLYCOLIC ACID suture is coated with a blend of polycaprolactone and calcium stearate. The POLYGLYCOLIC ACID suture has been found to be non-antigenic, and non-pyrogenic, and only causes a mild tissue reaction during the absorption process. The composition of the colored variant of polyglycolic acid suture is 96.1% - 99.2% polyglycolic acid, 0.4% - 2.2% polycaprolactone, 0.2% - 1.5% calcium stearate, and <0.2% D&C Violet No. 2. The composition of the uncolored variant of polyglycolic acid suture is 96.3% - 99.4% polyglycolic acid, 0.4% - 2.2% polycaprolactone, and 0.2% - 1.5% calcium stearate. POLYGLYCOLIC ACID sutures comply with the requirements established by the European Pharmacopoeia (E.P.) for sterile and absorbable synthetic braided sutures and the United States Pharmacopeia (U.S.P.) for absorbable synthetic surgical sutures. INTENDED USE: The polyglycolic acid suture is intended for use in the approximation and/or ligation of soft tissues, including for use in plastic and ophthalmic procedures, but not for use in cardiovascular and neurological tissues. INDICATIONS: Indicated in surgical procedures requiring a combination of absorbable sutures and short-term support for wound closure, approximation, and/or ligation of soft tissues. CONTRAINDICATIONS: Polyglycolic acid suture, being absorbable, should not be used where extensive tissue approximation is required. USERS: Only healthcare professionals who have been trained and registered. TARGET PATIENT POPULATION: This suture can be used in patients of any age and gender, in accordance with the intended use, indications, and contraindications. PERFORMANCE: Polyglycolic acid suture after implantation causes mild initial tissue inflammatory reaction and is eventually replaced by an increase in fibrous connective tissue. Polyglycolic acid suture, being absorbable in nature, is absorbed into tissues through hydrolysis, during which the polyglycolic acid polymer is degraded into glycolic acid, which is eventually absorbed and metabolized in the body. This absorption process initially leads to a progressive loss of tensile strength, followed by a loss of mass. Implantation studies in rats indicate that following implantation, the approximate percentage of remaining initial strength for polyglycolic acid suture is 82% at 14 days, 56% at 21 days, and 20% at 28 days, with complete absorption occurring essentially in about 90 days. APPLICATION: The suture should be selected and implanted based on the patient's condition, surgical experience, surgical technique, and wound size. WARNINGS: • This suture is intended to be used by a qualified and registered healthcare professional. • Users should be familiar with surgical procedures and techniques involving absorbable sutures before using polyglycolic acid sutures for wound closure, as the risk of wound dehiscence may vary depending on the application site and the suture material used. Users should consider in vivo performance when selecting a suture type. • Users should apply their professional judgment when determining the appropriate suture size, based on specific indication, wound size, preferred surgical technique, patient condition, and history. • The use of this type of suture may be inadequate in elderly, malnourished, or debilitated patients, or in patients with conditions that may delay wound healing. • Like any foreign body, prolonged contact of this suture with saline solutions, such as those found in the urinary or biliary tract, may lead to calculus formation. • Being an absorbable suture, it may transiently act as a foreign body, and like any foreign body, the presence of bacterial contamination may increase bacterial infectivity. Thus, proper surgical practice should be followed regarding drainage and closure of infected or contaminated wounds. • Wound dehiscence may occur when the suture fails to provide adequate wound support in closing areas where there is expansion, stretching, or distension. Therefore, the user should consider using additional non-absorbable sutures to close areas that may undergo expansion, stretching or distension or may require additional support. • In certain circumstances, especially in orthopedic procedures, external support immobilization may be used at the user's discretion. • It should be considered that the use of absorbable sutures in tissues with reduced blood flow may result in suture extrusion and delayed absorption. • Conjunctival, cuticular, and vaginal epithelial sutures left in place for prolonged periods may be associated with localized irritation and should be cut or removed as indicated. • Subcuticular sutures should be placed as deep as possible to minimize the erythema and induration normally associated with the absorption process. PRECAUTIONS: Care should be taken to avoid damage when handling surgical needles. Grasp the needle in an area between one-third (1/3) and one-half (1/2) the distance from the attachment end to the tip. Grasping at the tip area may affect penetration performance and cause needle breakage. Grasping at the head or attachment end area may cause bending or breaking of the needle. Reshaping needles can lead to loss of their strength and make them less resistant to bending and breaking. Broken needles may lead to prolonged or additional surgical interventions or residual foreign bodies. • Users should exercise caution when handling surgical needles to avoid unintentional needle stick injuries. Dispose of used needles in "Sharps" containers. • When handling this suture, attention should be paid to avoid damage from handling. Avoid damage from crushing or crushing due to the application of surgical instruments such as forceps or needle holders. • When necessary, straighten sutures with a gentle pull, without crushing or rubbing. • Like any suture material, proper knot security requires appropriate surgical techniques for tying flat and square knots, with additional knots justified by surgical circumstances and user experience. • Do not tie strips around suture packs, as these may damage the packs. • Do not resterilize, do not reuse. Reuse of this device (or portions of this device) may create a risk of product degradation, which may lead to device failure and/or cross-contamination, which may result in infection or transmission of bloodborne pathogens to patients and users. SIDE EFFECTS: Side effects associated with the use of polyglycolic acid sutures include allergic response in certain patients, transient local irritation at the wound site, transient foreign body inflammatory response, mild tissue inflammatory reaction, erythema, and induration during the absorption process of subcuticular sutures, and rarely, wound dehiscence. Like all foreign bodies, polyglycolic acid suture may exacerbate an existing infection. CLINICAL BENEFITS: The clinical benefits of this type of suture are: its lubricating coating creates a smooth surface, thereby reducing the friction coefficient, allowing smooth tissue passage, and ensuring minimal/absolute tissue pull and trauma. Its braided nature ensures a secure knot fixation capability compared to monofilament sutures. When used for tissue approximation and/or ligation following injury or surgery, it helps close dead space, minimizes blood loss and infection, and also aids wound healing. When used for skin edge approximation, it provides an aesthetic and functional outcome. Provides adequate initial tensile strength as per U.S.P. and E.P. requirements. Provides adequate short-term support during the critical wound healing period, even with smaller diameter sutures. Has a predictable absorption rate that allows decisions regarding suture application in relevant tissues and conditions, unlike natural sutures such as catgut, which do not have a predictable absorption rate. Is absorbed through the hydrolysis process allowing for a mild tissue reaction and inflammatory response. Being an absorbable suture, eliminates the discomfort of suture removal, unlike non-absorbable sutures, thereby saving surgeon time and reducing patient anxiety and discomfort. STERILITY: The polyglycolic acid suture is sterilized with ethylene oxide gas. Do not resterilize, do not reuse. Do not use it if the package is opened or damaged. Dispose of opened, unused sutures. STORAGE: Recommended storage conditions: Below 30°C, protected from moisture and direct sunlight. Do not use after the expiration date. Discover now the clinical benefits of PRIMA polyglycolic acid surgical sutures and provide your patients with the best surgical closure solutions.
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MPN 1840-TT3/8-16-3/0
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