SERALENE non absorbable blue (5/0) DS-18 needle of 75 CM box of 24 sutures - Serag & Wiessner (LO103414) - Delynov
Optimize tissue closure with SERALENE suture
This polyvinylidene fluoride (PVDF) monofilament offers exceptional stability and smooth tissue passage for your implantology and oral surgery procedures.
- Packaging: Box of 24 sutures.
- Gauge & Needle: USP 5/0, DS-18 needle (18 mm), 3/8 circle.
- Resorbability: Non-resorbable synthetic monofilament suture.
- Use: Soft tissue approximation and precision ligatures (75 cm length).
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-18 (18 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 non-absorbable SERALENE blue 5/0 suture?
SERALENE from the brand Serag-Wiessner is a synthetic and non-absorbable surgical suture material. This medical device comes in the form of a monofilament designed from polyvinylidene fluoride. Its monoblock structure gives it a smooth surface, thus limiting bacterial retention and facilitating sliding through tissues. Dyed blue (solvent blue, colour index nº 61568) for optimal visibility during interventions, this thread has a USP 5/0 calibre and a length of 75 cm. It meets the requirements of the European Pharmacopoeia monograph regarding sterile non-absorbable sutures (fila non resorbilia sterilia). This product is packaged in boxes of 24 units to meet the needs of operating theatres.
What are the clinical indications for SERALENE in surgery?
The SERALENE suture is specifically designed for the approximation of soft tissues or for performing ligatures requiring the use of a non-absorbable thread. Its mechanical properties and biocompatibility allow for varied use, notably in the central circulatory and nervous systems. In specialized practice, it is indicated in microsurgery and ophthalmology. This polyvinylidene fluoride thread can also serve as a support thread or as a marking tool during complex surgical procedures. The choice of material must be adapted by the practitioner according to the surgical techniques employed and the specific characteristics of the intervention site, thus guaranteeing precise and durable coaptation of the wound edges.
What are the technical characteristics of the DS-18 needle?
The LO103414 device is equipped with a technical needle referenced DS-18 made of surgical steel. The DS code designates a 3/8 circle needle equipped with a reverse cutting triangular point. This specific geometry is ideal for passing through dense tissues without causing undesirable tissue tearing, offering a clean and precise penetration. The number 18 indicates a needle length of 18 mm. Associated with the SERALENE thread of 5/0 calibre, this needle allows for fluid and secure handling, essential for precision gestures in oral or implant surgery. The robustness of the surgical steel used by Serag-Wiessner guarantees excellent resistance to torsion and a sharpness maintained throughout the suturing phase.
What are the contraindications for the use of this suture?
The use of SERALENE thread presents certain limits and contraindications defined by the manufacturer Serag-Wiessner GmbH & Co. KG. This device must not be used in patients with known or suspected allergies to any of its components, notably to polyvinylidene fluoride or the blue dye (solvent blue nº 61568). As with any implanted foreign body, prolonged contact with the biliary or urinary tracts can promote the formation of calculi. It is the surgeon's responsibility to evaluate the patient's history and read the instructions carefully before any application. Compliance with asepsis protocols and knowledge of potential interactions are essential to prevent post-operative complications related to the implantation of non-absorbable material.
What are the precautions related to the non-absorbable nature of the thread?
Being a non-absorbable suture, SERALENE retains its structural integrity and tensile strength in vivo, not undergoing hydrolysis or enzymatic degradation processes. This characteristic requires a rigorous knotting technique to ensure the stability of the suture points. The practitioner must take into account the specificities of the polyvinylidene fluoride monofilament during handling to avoid damaging the thread surface. Requirements in terms of material and techniques vary according to clinical indications. If used as a support or marking thread, subsequent removal must be planned in accordance with current surgical protocols, unless permanent maintenance is required for the stability of the concerned soft tissues.
Who is the manufacturer and what standards are respected?
The SERALENE suture is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. This medical device is classified as Class III, which corresponds to the highest level of requirement for implantable devices according to European regulations. It benefits from the CE1014 marking, guaranteeing its compliance with current safety and performance standards. The manufacturing process respects strict quality standards for sterile surgical sutures. Each box of 24 sutures is subject to rigorous controls to ensure the sterility and reliability of the material. Healthcare professionals can refer to the technical instructions to obtain all information relating to traceability and the manufacturer's recommendations for use.
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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