SERALENE non-absorbable blue (5/0) DS-15 needle 50 CM box of 24 sutures - Serag & Wiessner (LO101713) - Delynov
Optimize your tissue closures with SERALENE
SERALENE is a synthetic monofilament PVDF suture offering optimal tissue passage and long-term stability for your oral surgery procedures.
- Packaging: Box of 24 devices.
- Gauge & Needle: USP 5/0, DS-15 needle (15 mm, 3/8 circle).
- Resorbability: Non-resorbable (Polyvinylidene fluoride - PVDF).
- Use: Soft tissue approximation and ligatures in implantology and oral surgery.
Product features
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 50 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 SERALENE blue (5/0) from Serag-Wiessner?
SERALENE is a high-precision synthetic surgical suture material designed by the manufacturer Serag-Wiessner. This device is a non-absorbable monofilament made from polyvinylidene fluoride. Its monofilament structure provides a smooth surface, limiting tissue trauma during thread passage. Dyed blue (solvent blue, colour index nº 61568) for optimal visibility in the surgical field, this USP 5/0 gauge thread has a length of 50 cm. It is specifically developed to meet the requirements of microsurgery and interventions requiring great handling finesse. This product complies with European Pharmacopoeia requirements for sterile non-absorbable sutures.
What are the clinical indications for this suture?
SERALENE from Serag-Wiessner is indicated for soft tissue approximation and ligations requiring the use of a non-absorbable thread. In surgery, its use is particularly suited to fields requiring high precision such as the central nervous and circulatory systems, ophthalmology, as well as microsurgery. For dental surgeons and implantologists, it constitutes a choice solution for delicate sutures of the oral mucosa, where dimensional stability and the lack of capillarity of the monofilament are crucial. It can also serve as a support thread or a marking tool. Its use guarantees prolonged maintenance of the wound edges, essential in reconstruction or implantation protocols.
What are the technical characteristics of the DS-15 needle?
This reference LO101713 is equipped with a DS-15 needle made of high-quality surgical steel. The DS nomenclature designates a 3/8 circle needle equipped with a triangular reverse cutting tip. This geometry is ideal for passing through dense or keratinized tissues without causing accidental tearing, offering precise and controlled penetration. The number 15 indicates a needle length of 15 mm. Associated with the 5/0 gauge and the 50 cm thread length, this configuration allows for easy manipulation in the restricted spaces of the oral cavity, ensuring maximum safety during stitch placement.
What are the contraindications for the use of SERALENE?
The use of the SERALENE device is strictly contraindicated in patients with a known allergy to any of its components, notably polyvinylidene fluoride or the solvent blue dye. As with any foreign body, the manufacturer specifies that prolonged contact of this suture with the biliary or urinary tracts may promote the formation of calculi. It is the practitioner's responsibility to evaluate the choice of material based on the specific characteristics of the patient and the surgical technique employed. Careful reading of the instructions is imperative before any intervention to ensure the product's suitability for the clinical case being treated.
What are the precautions related to its non-absorbable nature?
As a non-absorbable suture, SERALENE maintains its tensile strength permanently in the tissues and does not undergo a degradation process by hydrolysis. This characteristic requires the practitioner to plan, if necessary, a subsequent step for the removal of the stitches once healing is achieved. During handling, it is recommended to take standard precautions related to synthetic monofilaments to ensure knot security. The choice of suture technique must take into account the mechanical properties of polyvinylidene fluoride to avoid any knot slippage or excessive tension on the soft tissues.
Who is the manufacturer and what standards are met?
SERALENE is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany, recognized for its expertise in suture devices. This product benefits from a rigorous regulatory classification as a Class III medical device, attesting to its high level of safety for invasive interventions. It bears the CE1014 marking, guaranteeing its compliance with current European requirements. Manufacturing respects the standards of the European Pharmacopoeia monograph for sterile non-absorbable sutures (fila non resorbilia sterilia), thus ensuring healthcare professionals a reliable, sterile, and high-performance material for their daily surgical acts.
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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