SERALENE non-absorbable blue (7/0) DSS-13 needle 50 CM box of 24 sutures - Serag & Wiessner (LO05171L) - 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-13 (13 mm), 3/8 circle, atraumatic triangular tip.
- Format: Thread length 50 cm, caliber 7/0 (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 (7/0) suture?
SERALENE from the brand Serag-Wiessner is a synthetic, monofilament, and non-absorbable surgical suture material. Designed from polyvinylidene fluoride, this thread is distinguished by its smooth and homogeneous structure. Dyed blue (solvent blue, colour index nº 61568) for optimal visibility during interventions, it features a 7/0 calibre, suitable for high-precision procedures. This Class III medical device meets the requirements of the European Pharmacopoeia for sterile non-absorbable sutures. Unlike braided sutures, its monofilament nature limits capillarity and the risk of bacterial colonization, offering a relevant technical alternative for medical suture and ligature equipment.
What are the clinical indications for this Serag-Wiessner device?
SERALENE is specifically designed for soft tissue approximation and ligatures requiring the use of a non-absorbable thread. In oral surgery and implantology, it is used for the management of delicate tissues. Its indications also extend to microsurgery, ophthalmology, as well as the central circulatory and nervous systems. This thread can also serve as a support thread or as a marking medium. Although it is not a direct equivalent to vicryl (which is absorbable and often braided), SERALENE 7/0 is preferred for precision sutures where long-term stability and minimal tissue reaction are required.
What are the technical characteristics of the DSS-13 needle?
The SERALENE LO05171L suture is equipped with a DSS-13 needle made of surgical steel. According to technical nomenclature, the DSS needle is a 3/8 circle needle featuring an atraumatic reverse cutting triangular point. This geometry is specifically designed to pass through delicate tissues and thin mucous membranes without causing unnecessary tearing. The number 13 indicates a needle length of 13 mm. Combined with a 50cm thread length, this configuration allows practitioners to perform surgical movements of great finesse, ensuring a smooth passage through soft tissues during the suture and ligature stages.
What are the contraindications for the use of this suture?
The use of the SERALENE device from Serag-Wiessner is strictly contraindicated in patients with known allergies to any of its components, particularly to polyvinylidene fluoride or the blue dye (solvent blue). Like any foreign body, this material may promote stone formation in the event of prolonged contact with the urinary or biliary tracts. It is imperative that the choice of suture material takes into account the clinical specificities and the specific characteristics of the material. Surgeons must carefully read the instructions to comply with the restrictions and limits of use defined by the manufacturer Serag-Wiessner GmbH & Co. KG.
What precautions are associated with the non-absorbable nature of the thread?
As SERALENE is a non-absorbable material, it retains its mechanical strength over time and does not undergo degradation processes by hydrolysis or proteolysis. This characteristic requires clinical monitoring to determine the appropriate timing for stitch removal, according to the established surgical protocol. Handling must be rigorous to avoid any damage to the monofilament, which could compromise knot security. Although search keywords sometimes include 45cm, this specific model offers a length of 50cm, providing additional ease of handling to secure sutures without excessive tension on the tissues.
Who is the manufacturer and what standards are met?
This medical device is manufactured by Serag-Wiessner GmbH & Co. KG, headquartered in Naila, Germany. The product bears the CE1014 marking, guaranteeing its compliance with European regulatory requirements for Class III medical devices. SERALENE complies with the European Pharmacopoeia monograph relating to sterile non-absorbable sutures (fila non resorbilia sterilia). The box contains 24 ready-to-use sutures, identified under reference LO05171L, ensuring full traceability for healthcare facilities and dental surgery practices specializing in the sale of high-quality medical equipment.
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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