SERALON non-absorbable blue (5/0) HR-15 needle 75 cm box of 24 sutures - Serag-Wiessner (VO103439) - Delynov
Optimize mucosal closures with SERALON suture
SERALON is a non-resorbable polyamide monofilament designed to provide optimal tissue passage and excellent tolerance during oral surgery procedures.
- Packaging: Box of 24 sterile sutures.
- Gauge & Needle: 5/0 gauge with 75 cm HR-15 needle.
- Resorbability: Non-resorbable (synthetic monofilament).
- Use: Indicated for oral surgery and implantology requiring material stability.
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: HR-15 (15 mm), 1/2 circle, round 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 Serag-Wiessner is a synthetic and non-absorbable surgical suture material. Designed from polyamide, this thread features a monofilament structure, ensuring a smooth surface for atraumatic passage through tissues. This 5/0 calibre medical device is colored blue using phthalocyanine (color index no. 74160) to ensure optimal visibility during surgical procedures. Compliant with the European Pharmacopoeia monograph for sterile non-absorbable sutures, it offers the mechanical properties necessary for maintaining tissue margins in protocols requiring an inert and synthetic material.
What are the clinical indications for this device?
This surgical suture is indicated for soft tissue approximation during procedures requiring non-absorbable material. In oral and implant surgery, monofilament SERALON is particularly suitable for flap sutures where low bacterial plaque accumulation is desired. The choice of this material must be made by the practitioner taking into account the specific characteristics of polyamide and the surgical techniques required by the indication. It is important to note that requirements vary according to clinical cases, and the surgeon must adapt their suturing technique to ensure optimal stability during the initial healing phase.
What are the technical characteristics of the HR-15 needle?
Reference VO103439 is equipped with an HR-15 needle swaged onto a 75 cm thread. According to the technical nomenclature, the HR code designates a 1/2 circle round-bodied needle. This needle profile is specifically indicated for deep sutures and ligatures, allowing precise penetration without excessive cutting effect on delicate tissues. The number 15 indicates a needle length of 15 mm. The combination of a 5/0 calibre thread and this precision needle allows the dental surgeon or oral surgeon to perform fine and secure sutures, adapted to the anatomy of the oral cavity.
What are the contraindications for the use of SERALON suture?
The use of SERALON suture material manufactured by Serag-Wiessner presents strict contraindications. It must never be used in direct contact with the heart, the central circulatory system, or the central nervous system. Furthermore, this device is contraindicated in patients with known allergies to polyamide or the dyes used (phthalocyanine blue). Finally, due to a risk of progressive loss of tensile strength in the body over time, these suture threads should not be used when prolonged and permanent stability of the material is an essential requirement for therapeutic success.
What are the precautions for use and the specificities of the knot?
As SERALON is a non-absorbable synthetic monofilament thread, it possesses high elasticity, particularly in thick diameters. To guarantee the safety and strength of the suture, the manufacturer Serag-Wiessner recommends performing one or two additional knots compared to standard practices. Like any foreign body, this device can promote calculus formation if it remains in prolonged contact with saline solutions (biliary or urinary tracts). In ophthalmic surgery, specific warnings also apply. The practitioner must carefully read the instructions to master the interactions and limitations of use related to the monofilament nature of the polyamide.
Who is the manufacturer and what standards are met?
This suture is manufactured by Serag-Wiessner GmbH & Co. KG, headquartered in Naila, Germany. The product benefits from a high level of regulatory compliance, being classified as a Class IIb medical device. It bears the CE1014 marking, guaranteeing compliance with European safety and performance requirements. The material is produced according to European Pharmacopoeia (EP) standards for sterile non-absorbable threads. Serag-Wiessner's traceability and manufacturing quality provide healthcare professionals with a reliable device for their daily surgical acts in dental practices or hospital environments.
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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