SERALON non-absorbable blue (4/0) DS-15 needle 75 CM box of 24 sutures - Serag & Wiessner (VO153413) - 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-15 (15 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: 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 SERALON blue 4/0 suture from Serag-Wiessner?
SERALON is a synthetic non-absorbable surgical suture material designed by Serag-Wiessner. It comes in the form of a monofilament thread made of polyamide (nylon). This medical device of 4/0 (USP) calibre has a smooth structure that facilitates passage through soft tissues while limiting bacterial plaque retention. The thread is colored blue using phthalocyanine (index no. 74160) to ensure optimal visibility during the surgical procedure. Each box contains 24 sterile sutures of 75 cm, ready to use for oral and implant surgery interventions. Its composition complies with the requirements of the European Pharmacopoeia (EP) relating to sterile non-absorbable sutures.
What are the clinical indications for this device?
The SERALON suture from Serag-Wiessner is indicated for the approximation of soft tissues during surgical interventions. In oral surgery, dentistry, and implantology, it is particularly suitable for flap sutures, extraction site closures, or during implant placement. Due to its monofilament nature, it is preferred when the aim is to minimize tissue trauma and reduce the risk of infection by capillarity. The choice of this material must be made by the practitioner, taking into account the specific characteristics of polyamide and the surgical techniques required for the relevant indication.
What are the technical characteristics of the DS-15 needle?
Reference VO153413 is equipped with a DS-15 needle. According to the 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 unwanted tearing. The number '15' indicates a needle body length of 15 mm. Combined with a 75 cm thread, this needle allows for precise and secure handling in the restricted spaces of the oral cavity, offering the surgeon smooth penetration and optimal directional control when performing stitches.
What are the contraindications for the use of SERALON?
The use of this suture material is strictly contraindicated for use in direct contact with the heart, the central circulatory system, and the central nervous system. Furthermore, the device must not be used in patients with known allergies to polyamide or the dyes used (phthalocyanine blue). The manufacturer Serag-Wiessner also specifies that these threads should not be used when prolonged stability of the suture material is essential over the very long term, due to a potential risk of loss of tensile strength in the body over time. The instructions for use should be read carefully before any use.
What are the precautions related to its non-absorbable nature?
As SERALON is a non-absorbable polyamide thread, it requires manual removal by the practitioner once initial healing is achieved. Special precaution must be taken when tying knots: due to the high elasticity of monofilament polyamide threads, it is recommended to perform one or two additional knots to ensure the strength and stability of the suture. Like any foreign body, this device can promote the formation of calculi if it remains in prolonged contact with salt-containing solutions. Finally, the practitioner must be vigilant regarding the risk of progressive loss of tensile strength in vivo, which is characteristic of polyamides.
Who is the manufacturer and what standards are respected?
This device is manufactured by Serag-Wiessner GmbH & Co. KG, headquartered in Naila, Germany. The product bears the CE1014 marking, guaranteeing its compliance with European regulatory requirements. It is classified as a Class IIb medical device. The SERALON suture complies with the current edition of the European Pharmacopoeia (EP) monograph concerning sterile non-absorbable sutures (fila non resorbiliasterilia). This compliance ensures healthcare professionals a high level of safety, sterility, and technical performance for their daily 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, optimizing keratinized gingival tissue thickness, and innovating composite materials.
Further reading on Delynov
- The Scientific Breakthrough Redefining Surgical Sutures: A Bulwark Against Infection
In the world of surgery, every detail is critical to ensuring procedural success and patient healing. One of the most closely monitored risks is surgical site infection… - Soft Tissue Management: The Apical Mattress Suture Increases Keratinized Gingival Thickness
Introduction The quality and quantity of peri-implant soft tissues are determining factors for the long-term success of treatments, influencing hygiene maintenance, the... - Innovation in Resorbable Sutures: A Cellulose and Propolis-Based Composite for Oral Surgery
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
| Manufacturer | Serag-Wiessner Suture Materials |
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