SERALON non-absorbable blue (5/0) DS-12 needle of 75 CM box of 24 sutures - Serag & Wiessner (VO103412) - Delynov
Optimize your mucosal closures with SERALON suture
SERALON is a non-resorbable synthetic monofilament thread designed to provide optimal tissue passage and excellent tolerance in oral surgery.
- Packaging: Box of 24 devices.
- Gauge & Needle: 5/0 gauge with DS-12 needle of 75 cm.
- Resorbability: Non-resorbable suture material (Polyamide).
- Use: Indicated for implant and periodontal surgery requiring material stability.
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-12 (12 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 from the brand Serag-Wiessner is a synthetic, non-absorbable surgical suture material. Made of polyamide, this thread features a monofilament structure, which provides it with a smooth surface and excellent tissue tolerance. This 5/0 calibre medical device is colored blue using phthalocyanine (index no. 74160) for optimal visibility during interventions. It complies with the European Pharmacopoeia monograph for sterile non-absorbable sutures. Its nylon composition ensures precise handling for demanding practitioners in oral and implant surgery.
What are the clinical indications for this device?
The SERALON from Serag-Wiessner is intended for the surgical suturing of soft tissues. In dental and oral surgery, it is particularly suitable for flap closure or implantology procedures requiring stable maintenance without material resorption. The choice of this suture must be made by the professional, taking into account the technical characteristics of the monofilament and the specific requirements of the surgical technique employed. Its non-absorbable nature allows for the maintenance of wound edge apposition for as long as necessary before manual removal by the practitioner.
What are the technical characteristics of the DS-12 needle?
Reference VO103412 is equipped with a DS-12 needle swaged onto a 75cm thread. According to technical nomenclature, the DS code designates a 3/8 circle needle with a triangular reverse cutting tip. This configuration is ideal for passing through dense tissues without causing undesirable tissue tearing. The number 12 indicates a needle length of 12mm, offering increased precision in the restricted spaces of the oral cavity. The combination of a 5/0 calibre and a DS-12 needle allows for smooth passage through the mucosa while minimizing trauma related to the insertion point.
What are the contraindications for the use of SERALON?
The use of this suture material is strictly contraindicated for direct contact with the heart, the central circulatory system, and the central nervous system. Furthermore, SERALON must not be used in patients with known allergies to polyamide or the dyes mentioned in its composition. Although classified as non-absorbable, there is a risk of progressive loss of tensile strength within the organism over time. Consequently, it should not be used when prolonged and indefinite stability of the suture material is essential for therapeutic success.
What are the precautions for use regarding knots and handling?
Due to the high elasticity characteristic of polyamide monofilament threads like SERALON, the manufacturer Serag-Wiessner recommends performing one or two additional knots to guarantee the strength and security of the suture. Like any foreign body, this device may promote the formation of calculi if it remains in prolonged contact with saline solutions, particularly in the biliary or urinary tracts. Practitioners must read the instructions carefully before use. It is also reminded that the device is for single use only and must not be used if the sterile packaging is damaged.
Who is the manufacturer and what standards are met?
This device is manufactured by Serag-Wiessner GmbH & Co. KG, headquartered in Naila, Germany. The product carries the CE1014 marking, guaranteeing its compliance with European regulatory requirements. It is classified as a Class IIb medical device. The manufacturing quality meets the standards of the European Pharmacopoeia (EP) for fila non resorbiliasterilia. Each box contains 24 sterile sutures, individually packaged to maintain product integrity until its use in the operating room or dental practice.
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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