SERALON non absorbable blue (5/0) DS-15 needle 75 CM box of 24 sutures - Serag & Wiessner (VO103413) - 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-15 (15 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 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 (5/0)?
SERALON by the brand Serag-Wiessner is a non-absorbable synthetic surgical suture material made of polyamide (nylon). This monofilament thread is distinguished by its smooth structure which limits capillarity and facilitates passage through soft tissues. Presented here in calibre 5/0 with a thread length of 75cm, it is colored blue (phthalocyanine blue) to ensure optimal visibility during the procedure. This medical device complies with the European Pharmacopoeia monograph regarding sterile non-absorbable sutures. It constitutes a reliable solution for practitioners seeking a quality alternative, sometimes compared in its category to references such as Dafilon or Filapeau.
What are the clinical indications for this monofilament suture?
SERALON (5/0) from Serag-Wiessner is intended for general use in surgical suturing. In oral surgery and implantology, it is particularly appreciated for flap closure and cutaneous or mucosal sutures requiring minimal tissue reaction due to its monofilament nature. Its 5/0 calibre allows for precise handling of delicate tissues. The choice of this material must be made by the practitioner taking into account the technical requirements of the procedure and the mechanical characteristics of the polyamide. It is important to note that this thread is not intended for indefinite prolonged stability due to a potential risk of loss of tensile strength in the body over time.
What are the technical characteristics of the DS-15 needle?
This reference VO103413 is equipped with a DS-15 needle. According to the technical nomenclature, the code DS designates a 3/8 circle needle equipped with a reverse cutting triangular point. This geometry is ideal for passing through dense or fibrous tissues without causing undesirable tissue tearing. The number 15 indicates a needle length of 15mm. Combined with a 75cm thread, this needle allows for great precision during suturing movements in narrow areas, offering surgeons an optimal balance between maneuverability and penetration during closure procedures.
What are the contraindications for the use of SERALON?
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 to the dyes used (phthalocyanine blue). As there is a risk of loss of tensile strength over the long term in the body, these nylon threads should not be used when prolonged stability of the suture material is essential. Finally, its prolonged use in contact with saline solutions (biliary or urinary tracts) can promote the formation of calculi, as with any foreign body.
What are the precautions for use regarding handling and knots?
Due to the high elasticity characteristic of polyamide monofilament threads, particular attention must be paid to knot security. The manufacturer Serag-Wiessner recommends performing one or two additional knots compared to braided threads to ensure the strength and stability of the suture. The practitioner must adapt their knotting technique to compensate for the shape memory of the monofilament. As it is a non-absorbable suture, SERALON maintains its structural integrity initially but requires clinical monitoring. It is imperative to read the instructions carefully before use to comply with all warnings and precautions related to ophthalmic or general surgery.
Who is the manufacturer and what safety standards are respected?
The SERALON suture is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. This medical device is certified Class IIb and bears the CE1014 marking, guaranteeing its compliance with current European regulatory requirements. The product is delivered in boxes of 24 sterile sutures, each unit being identified by the reference VO103413. The manufacturing quality meets the standards of the European Pharmacopoeia (EP) for fila non resorbiliasterilia. By choosing this product on Delynov, healthcare professionals ensure they are using a device that meets the strictest safety standards for their surgical interventions.
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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