SERALON non-absorbable blue (4/0) DS-12 needle of 50 CM box of 24 sutures - Serag & Wiessner (VO151712) - Delynov

What is blue non-absorbable SERALON (4/0)?

SERALON is a synthetic and non-absorbable surgical suture material developed by Serag-Wiessner. It is a monofilament suture made of polyamide, a material recognized for its smooth surface and biocompatibility. This polyamide suture thread has a USP calibre of 4/0 and a length of 50 cm. Its monofilament structure limits capillarity and the risk of bacterial accumulation at the surgical site, which is particularly advantageous during interventions in the oral cavity. The blue color, obtained by adding phthalocyanine blue (index no. 74160), ensures excellent visibility in the surgical field compared to surrounding tissues.

What are the clinical indications for this suture?

This non-absorbable suture is primarily intended for oral surgery, including implantology and periodontology. As a monofilament suture, it is ideal for flap closure and incisions where atraumatic tissue glide is required. The 4/0 calibre is suitable for procedures requiring moderate tensile strength while preserving surgical precision. It meets the requirements of the European Pharmacopoeia monograph for sterile non-absorbable sutures. The choice of this material must take into account specific technical characteristics and patient needs during surgical planning.

What are the technical characteristics of the DS-12 needle?

The needle equipped with this reference VO151712 is a DS-12 needle. According to technical nomenclature, the 'DS' code designates a 3/8 circle curvature needle with a triangular reverse cutting tip. This geometry is specifically designed to penetrate dense and fibrous tissues without causing undesirable tissue tearing, as the base of the cut is oriented towards the outside of the curvature. The number 12 indicates a needle body length of 12 mm, offering precise maneuverability in the restricted spaces of the oral cavity. This configuration is optimal for practitioners seeking clean penetration and total control during needle passage.

What are the contraindications for the use of SERALON?

The manufacturer Serag-Wiessner GmbH & Co. KG specifies several strict contraindications for the use of this device. SERALON suture material is formally contraindicated for any use involving direct contact with the heart, central circulatory system, or central nervous system. Furthermore, it must not be used in patients with known allergies to polyamide or the dyes used. Finally, although it is classified as non-absorbable, there is a potential risk of loss of tensile strength in the body over the very long term. Consequently, it should not be used when prolonged and indefinite stability of the suture material is essential.

What precautions should be taken for knots and handling?

Due to the monofilament nature of polyamide, this thread exhibits high elasticity, particularly in large diameters. To guarantee the safety and strength of the 4/0 non-absorbable suture, the manufacturer recommends making one or two additional knots compared to classic braided sutures. This precaution prevents the risk of knot slippage. Furthermore, like any foreign body, the device may promote stone formation if it remains in prolonged contact with saline solutions (biliary or urinary tracts). In ophthalmic surgery, specific warnings also apply. It is imperative to read the instructions carefully before any clinical use.

Who is the manufacturer and what standards are respected?

SERALON is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. This medical device is classified as Class IIb according to current regulations. It benefits from CE1014 marking, guaranteeing its compliance with European safety and performance requirements. Production follows rigorous protocols to ensure the sterility and quality of the material. The product is delivered in boxes of 24 ready-to-use sutures, each thread being individually packaged to maintain its integrity. Compliance with the 'sterile non-absorbable sutures' monograph of the European Pharmacopoeia confirms Serag-Wiessner's position as a recognized manufacturer of high-precision surgical devices.

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.