SERALENE non-absorbable blue (5/0) DSS-13 needle 50 CM box of 24 sutures - Serag & Wiessner (LO10171L) - Delynov

What is SERALENE non-resorbable blue (5/0)?

SERALENE by the brand Serag-Wiessner is a synthetic, monofilament, and non-resorbable surgical suture material. This non-resorbable suture thread is manufactured from polyvinylidene fluoride, a polymer offering a smooth and homogeneous structure. For optimal visibility during the operative act, the thread is tinted blue (Solvent Blue, Colour Index nº 61568). With a 5/0 (USP) calibre and a length of 50cm, this device is packaged in boxes of 24 sterile sutures. It meets the requirements of the European Pharmacopoeia for sterile non-absorbable sutures (fila non resorbilia sterilia). This product is classified as a Class III medical device and bears the CE1014 marking.

What are the clinical indications for this suture?

SERALENE is specifically indicated for soft tissue approximation and performing ligatures requiring a non-resorbable material. In surgery, its use extends to the central circulatory and nervous systems, as well as microsurgery and ophthalmology. For dental surgeons and implantologists, this surgical suture thread purchase is particularly suitable for interventions requiring great finesse in handling. Polyvinylidene fluoride threads can also be used as support threads or as a means of marking. The choice of this material must always be guided by the technical characteristics of the thread and the specific requirements of the surgical technique employed by the practitioner.

What are the technical characteristics of the DSS-13 needle?

Reference LO10171L is equipped with a DSS-13 technical needle. According to the Delynov nomenclature, the code DSS corresponds to a 3/8 circle needle equipped with an atraumatic reverse cutting triangular point. This geometry is specifically designed for the penetration of delicate tissues and thin mucous membranes, minimizing tissue trauma during the passage of the thread. The number 13 indicates a needle length of 13mm. Manufactured in high-quality surgical steel by Serag-Wiessner GmbH & Co. KG, this needle is securely swaged to a 50cm thread, guaranteeing a fluid transition between the needle and the monofilament to preserve the integrity of the wound edges.

What are the contraindications for the use of SERALENE?

The use of SERALENE presents specific contraindications defined by the manufacturer Serag-Wiessner. This medical device must never be used in patients with a known allergy to any of its components, notably polyvinylidene fluoride or the dye Solvent Blue (nº 61568). Furthermore, as with any surgical foreign body, prolonged contact of the suture with the biliary or urinary tracts can promote the formation of calculi. It is the surgeon's responsibility to evaluate the patient's allergic history before any intervention and to choose the suture material taking into account the restrictions and limits of use mentioned in the manufacturer's technical instructions.

What are the precautions related to this non-resorbable thread?

As a non-resorbable dental suture, SERALENE maintains its tensile strength permanently in the tissues. Unlike resorbable materials, it does not undergo hydrolysis and requires manual removal once healing is obtained, according to the chosen clinical protocol. During handling, the practitioner must take into account the properties of the monofilament for knotting to ensure maximum safety. Although this product is sometimes compared to a polypropylene suture by some practitioners for its physical properties, its polyvinylidene fluoride composition is unique to it. Particular attention must be paid to the choice of the 5/0 calibre to ensure it corresponds to the mechanical resistance required for the anatomical site concerned.

Who is the manufacturer and what standards are respected?

SERALENE is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized manufacturer located in Naila, Germany. This Class III medical device complies with the strictest European standards, as evidenced by its CE1014 marking. Production respects the requirements of the European Pharmacopoeia monograph relating to non-absorbable sterile sutures. Each box of 24 units (reference LO10171L) is subject to rigorous controls to guarantee the sterility and technical performance of the monofilament and the DSS-13 needle. Professionals can refer to the instructions for use for all warnings and precautions for use provided by the German manufacturer.

State of the art

Modern synthetic sutures - absorbable or non-absorbable - are central to wound healing in oral surgery. Recent advances focus on reducing post-operative infections.