SERALENE non-absorbable blue (6/0) DSS-10 needle of 50 CM box of 24 sutures - Serag & Wiessner (LO07171S) - Delynov
Optimize your precision sutures with SERALENE
The SERALENE monofilament offers exceptional tissue glide and long-lasting stability for your oral surgery and implantology procedures.
- Packaging: Box of 24 sutures.
- Gauge & Needle: 6/0 gauge with DSS-10 needle (50 cm).
- Resorbability: Non-resorbable synthetic monofilament suture (PVDF).
- Use: Soft tissue approximation and microsurgery.
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-10 (10 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 non-absorbable blue SERALENE suture (6/0)?
SERALENE from the brand Serag-Wiessner is a synthetic, monofilament, and non-absorbable surgical suture material. Made from polyvinylidene fluoride, this suture thread is distinguished by its monofilament structure which limits bacterial adhesion and facilitates passage through tissues. This Class III medical device is dyed blue (solvent blue, colour index nº 61568) to ensure optimal visibility during the operative procedure. It is presented here in a 6/0 calibre, packaged in boxes of 24 sutures of 50cm in length. This material strictly complies with the requirements of the European Pharmacopoeia regarding sterile non-absorbable sutures.
What are the clinical indications for SERALENE (6/0)?
The SERALENE suture from Serag-Wiessner is indicated for the approximation of soft tissues or for performing ligatures requiring the use of a non-absorbable thread. Its use extends to microsurgery, ophthalmology, as well as interventions on the central circulatory and nervous systems. For dental surgeons and implantologists, this thread is particularly suitable for procedures requiring high precision. In addition to its role as a suture, polyvinylidene fluoride can serve as a support thread or a marking medium. Its non-absorbable nature guarantees prolonged mechanical support over time, which is essential for certain tissue reconstructions.
What are the technical characteristics of the DSS-10 needle?
This reference LO07171S is equipped with a DSS-10 needle made of surgical steel. According to technical nomenclature, the code DSS corresponds to a 3/8 circle needle featuring an atraumatic reverse cutting triangular point. This configuration is specifically designed for the penetration of delicate tissues and thin mucous membranes, minimizing tissue trauma during thread passage. The number 10 indicates a needle length of 10 mm. Combined with a 6/0 calibre thread, this needle allows for extremely fine manipulation, meeting the requirements of the most meticulous oral and periodontal surgeries.
What are the contraindications for the use of this suture?
The use of SERALENE is contraindicated in patients with known allergies to any of its components, particularly to polyvinylidene fluoride or the dye solvent blue (nº 61568). As with any foreign body, the manufacturer Serag-Wiessner GmbH & Co. KG specifies that prolonged contact of this device with the urinary or biliary tracts may promote calculus formation. It is imperative that the practitioner adapts the choice of suture material and knotting techniques according to the specific clinical indications and the patient's condition.
What are the precautions related to the non-absorbable nature of the thread?
Since SERALENE is a non-absorbable thread, it does not undergo degradation by hydrolysis and maintains its structural integrity over the long term. The choice of this type of thread implies rigorous knot management to ensure the stability of tissue approximation. The practitioner must take into account the specific characteristics of polyvinylidene fluoride during handling. Unlike absorbable sutures, this material requires a subsequent intervention for its removal if the clinical indication so provides. It is essential to read the instructions carefully to respect the restrictions and limits of use defined by the manufacturer.
Who is the manufacturer and what standards are met?
These sutures are manufactured by Serag-Wiessner GmbH & Co. KG, headquartered in Naila, Germany. This medical device is certified Class III and bears the CE1014 marking, guaranteeing its compliance with European regulatory requirements (MDR). The base material, polyvinylidene fluoride, meets the standards of the European Pharmacopoeia monograph relating to sterile non-absorbable sutures (fila non resorbilia sterilia). Product traceability and safety are ensured by compliance with these rigorous manufacturing standards, providing healthcare professionals with a reliable device for their surgical interventions.
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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