SERALENE non-absorbable blue (5/0) DS-15 needle of 75 CM box of 24 sutures - Serag & Wiessner (LO103413) - 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: DS-15 (15 mm), 3/8 circle, triangular reverse cutting tip.
- Format: Thread length 75 cm, caliber 5/0 (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 suture (5/0)?
SERALENE from the brand Serag-Wiessner is a synthetic, monofilament, and non-absorbable surgical suture material. Designed from polyvinylidene fluoride, this thread offers a smooth and homogeneous structure limiting bacterial adhesion. This 5/0 calibre medical device is dyed blue (solvent blue, colour index nº 61568) to ensure optimal visibility during the surgical procedure. As a monofilament, it is recognized for its flexibility and its ability to glide through soft tissues without a sawing effect. Although it shares certain indications with nylon-type sutures or references like the Filapeau equivalent, SERALENE is distinguished by its specific polyvinyl fluoride composition, meeting the requirements of the European Pharmacopoeia for sterile non-absorbable sutures.
What are the clinical indications for this Serag-Wiessner suture?
The SERALENE suture is indicated for soft tissue approximation or for ligatures requiring the use of non-absorbable suture thread. Its use is particularly suitable in microsurgery, ophthalmology, as well as in the central circulatory and nervous systems. In oral surgery and implantology, this 75cm monofilament is used for its biocompatibility and strength. Polyvinyl fluoride threads can also serve as support threads or marking means. The choice of material must systematically take into account the technical characteristics of the product and the specific needs of the surgical intervention to guarantee optimal tissue healing.
What are the technical characteristics of the DS-15 needle?
Reference LO103413 is equipped with a DS-15 needle made of surgical steel. According to the technical nomenclature, the code DS designates a 3/8 circle needle with a triangular reverse cutting point. This geometry is ideal for passing through dense tissues without causing undesirable tissue tearing. The number 15 indicates a needle length of 15 mm. Combined with a 75cm thread, this needle allows for precise handling during delicate sutures. The combination of the 5/0 calibre and the DS-15 needle offers a perfect balance between fineness and resistance for demanding practitioners.
What are the contraindications for the use of SERALENE?
The use of the SERALENE device is contraindicated in patients with known allergies to any of its components, notably polyvinylidene fluoride or the solvent blue dye. As with any foreign body, prolonged contact of this suture with the biliary or urinary tracts can promote the formation of stones. It is imperative to read the instructions carefully before use. The surgeon must adapt their suturing technique according to the characteristics of the material, as requirements vary according to the clinical indications encountered.
What are the precautions related to the non-absorbable nature of the thread?
As SERALENE is a non-absorbable material, it does not undergo degradation by hydrolysis or proteolysis. It remains stable in the body, which requires appropriate clinical monitoring. Unlike a Vicryl equivalent which is absorbable, SERALENE must be manually removed once healing is achieved, according to the post-operative protocol defined by the practitioner. During placement, particular attention must be paid to the realization of knots to ensure their security, while avoiding excessive tension on the wound edges. Its monofilament structure limits inflammatory risks related to the transport of fluids or bacteria.
Who is the manufacturer and what standards are met by this product?
This suture is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. The product benefits from a Class III regulatory classification, testifying to its high level of safety for invasive interventions. It bears the CE1014 marking, guaranteeing its compliance with current European requirements. The polyvinylidene fluoride-based suture materials used by Serag-Wiessner comply with the European Pharmacopoeia monograph relative to sterile non-absorbable sutures (fila non resorbilia sterilia). The box contains 24 ready-to-use sutures, each with a length of 75cm.
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
| Manufacturer | Serag-Wiessner Suture Materials |
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