SERALON non-absorbable blue (4/0) DS-18 needle of 75 CM box of 24 sutures - Serag & Wiessner (VO153414) - Delynov
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 4/0 (USP).
- Packaging: Box of 24 single-use sterile sutures.
- Compliance: Medical device Class IIb, 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 (4/0)?
SERALON by the brand Serag-Wiessner is a synthetic, non-absorbable, and sterile surgical suture material. It is a monofilament thread designed in polyamide, a material recognized for its smooth surface and biocompatibility. This medical device complies with the European Pharmacopoeia (EP) monograph relating to sterile non-absorbable sutures. Offered here in 4/0 calibre with a 75cm thread, it is distinguished by its blue color, obtained thanks to phthalocyanine blue, facilitating its visibility during interventions. This product is often considered a Filapeau equivalent in clinical practice. Its monofilament structure limits the risks of bacterial colonization, which is essential for maintaining post-operative asepsis.
What are the clinical indications for this Serag-Wiessner suture?
SERALON is intended for general surgical suturing. In oral surgery and implantology, this monofilament thread is particularly appreciated for closing soft tissues. Its flexibility and non-capillary structure allow for precise handling for the approximation of gingival margins. The choice of material must, however, take into account the specific characteristics of each intervention and the required technical requirements. Thanks to its 4/0 calibre, it offers an optimal balance between tensile strength and fineness, limiting tissue trauma during needle passage. It is suitable for practitioners seeking a reliable suture for procedures requiring tissue maintenance without spontaneous resorption.
What are the technical characteristics of the DS-18 needle?
The DS-18 needle equipped with this SERALON suture has specific properties for dental and oral surgery. The "DS" code means that it is a 3/8 circle needle with a triangular reverse cutting tip. This geometry is ideal for passing through dense or keratinized tissues without causing unwanted tears, as the cutting edge is located on the outer curvature of the needle. The number "18" indicates a length of 18mm, offering maneuverability adapted to the restricted spaces of the oral cavity. Combined with a 75cm thread, this needle allows for fluid execution of stitches while guaranteeing precise and secure penetration into the mucous membranes.
What are the contraindications for the use of SERALON?
The use of Serag-Wiessner SERALON suture material presents certain strict contraindications according to manufacturer data. It is formally contraindicated for use in direct contact with the heart, the central circulatory system, as well as the central nervous system. Furthermore, this device must not be used in patients with a known allergy to polyamide or the dyes composing the thread. It is also specified that these sutures should not be used when prolonged stability of the material is essential over the very long term, due to a potential risk of progressive loss of tensile strength within the body over time.
What are the precautions for use and knot management?
Although SERALON is a non-absorbable suture, specific precautions apply. Due to the high elasticity characteristic of polyamide monofilament threads, the manufacturer Serag-Wiessner recommends making one or two additional knots compared to braided sutures to ensure optimal strength and prevent slipping. As with any foreign body, prolonged contact with saline solutions (such as bile or urine) can promote the formation of calculi. In oral surgery, post-operative monitoring is necessary until manual removal of the stitches, as the thread does not resorb by hydrolysis. Handling must be careful not to damage the monofilament structure during knotting.
Who is the manufacturer and what standards are respected?
These sutures are manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. The product benefits from rigorous certification, classified as a Class IIb medical device. It bears the CE1014 marking, guaranteeing its compliance with European safety and performance requirements. Production respects European Pharmacopoeia standards for non-absorbable threads. Each box contains 24 sterile sutures, referenced under the code VO153414 at Delynov. Compliance with these strict standards ensures dental surgeons and implantologists high-quality, reliable, and secure material for their daily operative 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
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