SERALENE non-absorbable blue (6/0) DSS-15 needle of 50 CM box of 24 sutures - Serag & Wiessner (LO07171T) - Delynov
The SERALENE suture by Serag-Wiessner GmbH & Co. KG is a non-absorbable monofilament synthetic medical device, indicated for oral surgery and implantology where prolonged material stability is required.
- Material: de suture chirurgicale, monofilament, synthétique et non résorbable. le matériau de base du fil est le polyfluorure de vinylidène. seralene® est teinté en solvent blue, colour index nº 61568..
- Type: Non-absorbable (suture removal required after healing).
- Needle: DSS-15 (15 mm), 3/8 circle, atraumatic triangular tip.
- Format: Thread length 50 cm, caliber 6/0 (USP).
- Packaging: Box of 24 single-use sterile sutures.
- Compliance: Medical device Class III, CE marking CE1014.
- Manufacturer: Serag-Wiessner GmbH & Co. KG.
fabricant : serag-wiessner gmbh & co. kg, zum kugelfang 8-12, 95119 naila/germany - usage prévu : suture surgical : description et emploi prévu seralene® est un matériau de suture chirurgicale, monofilament, synthétique et non résorbable. le matériau de base du fil est le polyfluorure de vinylidène. seralene® est teinté en solvent blue, colour index nº 61568. seralene® est disponible en différents calibres et longueurs. il est fourni avec différents types d'aiguilles en acier chirurgical ou sans aiguille. il peut être associé à d'autres composants, comme un tube de guidage de suture. seralene® peut contenir des compresses destinées à renforcer les structures corporelles. les matériaux de suture à base de polyfluorure de vinylidène sont conformes aux exigences sous-jacentes de la monographie de la pharmacopée européenne «sutures stériles non-absorbables» (fila non resorbilia sterilia). seralene® est conçu pour le rapprochement des tissus mous ou pour les ligatures nécessitant l‘utilisation de fil de suture non résorbable, y compris l'utilisation au niveau des systèmes circulatoire et nerveux centraux, ainsi qu'en microchirurgie et en ophtalmologie. les fils de fluorure en polyvinyle peuvent également servir de fils de soutien et de moyen de marquage. - lire attentivement la notice. avertissement et précautions : contre-indications le dispositif ne doit pas être utilisé chez les patients présentant des allergies à l'un des composants du produit. restrictions et limites d'utilisation / remarques / interactions les exigences en termes de matériel de suture et de techniques nécessaires varient suivant les indications. le choix du matériel de suture doit tenir compte des caractéristiques du matériel de suture concerné. comme tous les corps étrangers, le dispositif peut provoquer la formation de calculs lors d'un contact prolongé avec les voies biliaires ou urinaires. l'utilisation de mesures auxiliaires adaptées est recommandée pour les sutures dans des tissus infectés. les instruments chirurgicaux doivent être maniés avec soin pour éviter d'endommager la suture. les aiguilles peuvent se casser si on les plie ou si on les tient en dehors de la zone recommandée. étant donné le risque d’infection qu’entraînent les piqûres d’aiguilles, celles-ci doivent être manipulées avec le maximum de précaution. – dispositif médical - réservé aux professionnels de santé.
What is the SERALENE non-absorbable blue (6/0) suture?
SERALENE is a synthetic, monofilament, non-absorbable surgical suture material designed by Serag-Wiessner. Its structure is composed of polyvinylidene fluoride, a polymer offering a smooth surface and excellent tissue tolerance. This 6/0 calibre thread is tinted blue (solvent blue, colour index nº 61568) to ensure optimal visibility during delicate interventions. As a monofilament, it limits the risks of capillarity and bacterial colonization compared to braided threads. This medical device is packaged in boxes of 24 sutures of 50cm each, meeting the requirements of the European Pharmacopoeia for sterile non-absorbable sutures. It constitutes a technical solution of choice for practitioners seeking a high-performance blue thread, sometimes compared to references like equiv:filapeau.
What are the clinical indications for this Serag-Wiessner suture?
The SERALENE suture is specifically designed for soft tissue approximation and ligatures requiring the use of a non-absorbable thread. Its mechanical properties and biocompatibility allow its use in demanding fields such as microsurgery, ophthalmology, as well as in the central circulatory and nervous systems. In oral surgery and implantology, this 6/0 thread is particularly suitable for managing flaps and delicate tissues. Polyvinylidene fluoride threads can also serve as support sutures or as a means of marking. The choice of this suture material must always take into account the specific characteristics of the device and the surgical techniques employed by the practitioner.
What are the technical characteristics of the DSS-15 needle?
The needle equipping this reference LO07171T is a DSS-15 needle made of surgical steel. According to technical nomenclature, the DSS code corresponds to a 3/8 circle needle equipped with an atraumatic reverse-cutting triangular point. This configuration is specifically designed to facilitate penetration into dense tissues or thin mucous membranes without causing excessive tearing. The number 15 indicates a length of 15 mm for the needle body. Associated with a 50cm thread, this DSS-15 needle allows for precise manipulation during precision suturing, guaranteeing a smooth passage through soft tissues while maintaining excellent stability when held in the needle holder.
What are the contraindications for the use of SERALENE?
The use of the SERALENE device presents certain limits and important contraindications to be respected. It must not be used in patients with known allergies to polyvinylidene fluoride or to the blue dye (solvent blue nº 61568) used for the thread. As with any foreign body, prolonged contact with physiological secretions, particularly in the biliary or urinary tracts, can promote the formation of calculi. It is imperative that the surgeon adapts the choice of suture material according to the clinical indication and the patient's condition. A careful reading of the instructions for use provided by the manufacturer Serag-Wiessner is indispensable before any intervention.
What precautions are linked to the non-absorbable nature of this thread?
As SERALENE is a non-absorbable thread, it retains its mechanical strength over time and does not undergo degradation processes through hydrolysis or proteolysis. This characteristic requires post-operative monitoring to decide the appropriate time for stitch removal, in accordance with standard clinical protocols. During placement, the practitioner must ensure the creation of secure knots, as the smooth surface of the polyvinylidene fluoride monofilament requires a precise knotting technique to avoid any slipping. The length of 50cm offers sufficient ease of handling to secure sutures without excessive tension. It is reminded that this device is for single use and must not be resterilized.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. The product is classified as a Class III medical device, which demonstrates its high level of compliance and safety for complex surgical interventions. It benefits from CE1014 marking, guaranteeing compliance with current European regulatory requirements (MDR). The materials used for the manufacture of SERALENE comply with the European Pharmacopoeia monograph relating to sterile non-absorbable sutures (fila non resorbilia sterilia). German manufacturing quality and traceability ensure dental surgeons and implantologists a reliable material for their daily procedures.
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.
Specifications
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