SERALON non-absorbable blue (5/0) DS-18 needle of 75 CM box of 24 sutures - Serag & Wiessner (VO103414) - Delynov
Product features
The SERALON 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: Polyamide (Nylon).
- 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: Class IIb medical device, CE marking CE1014.
- Manufacturer: Serag-Wiessner GmbH & Co. KG.
fabricant : serag-wiessner gmbh & co. kg, zum kugelfang 8-12, 95119 naila/allemagne usage prévu : suture chirurgicale description et emploi : nylon, seralon® et supramid sont des matériels de suture chirurgicaux synthétiques et non résorbables constitués de polyamide. le matériel de suture est conforme à l'édition actuelle de la monographie de la pharmacopée européenne (pe) «sutures stériles non résorbables (fila non resorbiliasterilia)». seralon® bleu et non coloré seralon® est un fil monofilament. seralon® bleu est coloré au bleu de phtalocyanine, indice de couleur no. 74160.
lire attentivement la notice. avertissements et précautions :
contre-indications : le matériau de suture est contre-indiqué pour un usage en contact direct avec le cœur, l’appareil circulatoire central et le système nerveux central. étant donné le risque de perte de résistance à la tension dans l’organisme, il ne faut pas les utiliser quand une stabilité prolongée du matériel de suture est indispensable. 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. en raison de la grande élasticité des fils monofilamenteux épais de polyamide, il est recommandé de faire un ou deux nœuds supplémentaires pour assurer la solidité de la suture. comme tout corps étranger, le dispositif peut provoquer la formation de calculs quand il reste en contact prolongé avec des solutions contenant du sel (p. ex. dans les voies biliaires ou urinaires). quand les fils de polyamide sont utilisés en chirurgie ophtalmique, il faut garder à l’esprit les avertissements suivants : les patients qui subissent une intervention oculaire exigent une observation prolongée ; les fils de polyamide situés sur la cornée doivent être enlevés après 3 à 12 mois ; l’irradiation laser accélère la rupture intratissulaire des fils de polyamide. il faut préférer les fils monofilamenteux (seralon®, nylon) comme matériel de suture pour les sutures dans les tissus infectés ou les tissus présentant un risque d’infection.
les instruments chirurgicaux doivent être manipulés avec précaution pour éviter d’endommager les fils. il ne faut pas plier les aiguilles ou les saisir en dehors de la zone recommandée pour éviter qu’elles se brisent. étant donné le risque d’infection qu’entraînent les piqûres d’aiguilles, celles-ci doivent être manipulées avec le maximum de précaution.
réservé aux professionnels de santé.
What is the non-absorbable blue SERALON suture (5/0)?
SERALON from the brand Serag-Wiessner is a synthetic, non-absorbable surgical suture material made from polyamide (nylon). This medical device comes in the form of a monofilament thread, offering a smooth structure that facilitates passage through tissues. Its blue color, achieved through the use of phthalocyanine blue (index no. 74160), ensures optimal visibility during the procedure. Compliant with the European Pharmacopoeia (EP) for sterile non-absorbable sutures, this 5/0 calibre thread has a length of 75 cm. It is specifically developed to meet the requirements of surgeons seeking a reliable and inert synthetic material.
What are the clinical indications for this device?
The SERALON suture is indicated for general surgical use requiring soft tissue approximation. In oral, dental, and implant surgery, this polyamide monofilament is particularly valued for its biocompatibility and its ability to minimize bacterial plaque retention compared to braided threads. However, the choice of material must take into account the specific characteristics of polyamide and the surgical techniques employed. It is imperative to read the instructions carefully to adapt the use to specific clinical needs. This device from Serag-Wiessner is a reference choice for practitioners requiring a high-quality synthetic non-absorbable suture.
What are the technical characteristics of the DS-18 needle?
The suture VO103414 is equipped with a DS-18 needle. According to technical nomenclature, the 'DS' code designates a 3/8 circle needle with a triangular reverse cutting tip. This geometry is ideal for passing through dense or keratinized tissues without causing undesirable tissue tearing. The number '18' indicates that the needle has a length of 18 mm. This configuration, combined with a 5/0 calibre thread and a length of 75 cm, allows for precise and secure handling during oral surgery procedures, guaranteeing smooth penetration and optimal control of the needle path.
What are the contraindications for the use of SERALON suture?
The use of SERALON suture material is strictly contraindicated for direct contact with the heart, the central circulatory system, and the central nervous system. Furthermore, this device must not be used in patients with known allergies to polyamide or the dyes used. Due to the potential risk of loss of tensile strength within the body over time, it is not suitable for procedures where prolonged and permanent stability of the suture material is essential. The manufacturer Serag-Wiessner also specifies that the device may cause stone formation in case of prolonged contact with saline solutions, such as in the urinary or biliary tracts.
How is this non-absorbable suture managed?
As SERALON is a non-absorbable polyamide thread, it does not undergo degradation by hydrolysis. However, a certain loss of tensile strength may occur gradually in the body. Particular care must be taken when tying knots: due to the high natural elasticity of polyamide monofilament threads, it is strongly recommended to perform one or two additional knots compared to standard practices to ensure the strength and security of the suture. In ophthalmic surgery, specific warnings also apply. Practitioners must adapt their knotting technique to compensate for the shape memory and elasticity of the monofilament.
Who is the manufacturer and what standards are met?
This medical device is manufactured by Serag-Wiessner GmbH & Co. KG, located in Naila, Germany. The product is classified as a Class IIb device and bears the CE1014 marking, guaranteeing its compliance with European regulatory requirements for medical devices. Manufacturing strictly adheres to the current European Pharmacopoeia (EP) monograph concerning sterile non-absorbable sutures (fila non resorbiliasterilia). Each box contains 24 sterile, ready-to-use sutures. Compliance with these rigorous standards provides dental surgeons and implantologists with a high-safety product, whose traceability and technical performance are validated by the competent authorities.
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, optimizing keratinized gingival tissue thickness, and innovating composite materials.
Further reading on Delynov
- The Scientific Breakthrough Redefining Surgical Sutures: A Bulwark Against Infection
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Introduction Suture material, the earliest known type of implant in history, is a fundamental component of surgery. An ideal material must combine several demanding properties: high tensile strength, biocompatibility, and optimal biological integration.
Specifications
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