SERAMON non-absorbable colorless (5/0) DS-15 needle 50 CM box of 24 sutures - Serag & Wiessner (MEO101713) - Delynov
Product features
The SERAMON 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: de base du fil de suture se compose de polytétrafluoréthylène (ptfe). seramon® est proposé exclusivement non coloré. il est disponible dans des calibres et longueurs de fil différents..
- Type: Non-absorbable (suture removal required after healing).
- Needle: DS-15 (15 mm), 3/8 circle, triangular reverse cutting tip.
- Format: Thread length 50 cm, caliber 5/0 (USP).
- Packaging: Box of 24 single-use sterile sutures.
- Compliance: Medical device Class III, 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 :seramon® est un matériel de suture chirurgical synthétique, monofil et non résorbable. le matériau de base du fil de suture se compose de polytétrafluoréthylène (ptfe). seramon® est proposé exclusivement non coloré. il est disponible dans des calibres et longueurs de fil différents. les matériels de suture en ptfe sont fournis en assortiments avec divers types d’aiguille en acier chirurgical ou sans aiguille. des pledgets destinés à renforcer les structures corporelles endogènes peuvent être fournis avec seramon®. les matériels de suture sont conformes aux exigences de l’édition actuelle de la monographie de la pharmacopée européenne (ph. eur.) concernant les « matériaux de suture stériles, non résorbables (fila non resorbilia sterilia) », à l’exception d’éventuels écarts négligeables concernant le diamètre du fil. seramon® est prévu pour l’adaptation des tissus mous ou pour la ligature, pour lesquelles un matériel de suture non résorbable est indiqué, y compris l’utilisation dans le système circulatoire et nerveux central. les fils en ptfe peuvent également servir de fils de soutien et de moyen de marquage. lire attentivement la notice. avertissements et précautions : contre-indications : 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 : on ne dispose encore d’aucune expérience suffisante dans la microchirurgie, en ophtalmologie et dans le domaine des interventions chirurgicales sur les nerfs périphériques. 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. comme tout corps étranger, le dispositif peut provoquer la formation de calculs quand il reste en contact prolongé avec les voies biliaires ou urinaires. seramon® peut, compte tenu de sa structure monofil, être utilisé aussi dans les tissus présentant un risque d’infection. lors de l’utilisation pour suturer des tissus infectés, il est recommandé d’appliquer des mesures d’accompagnement appropriées. 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 inhérent aux piqûres d’aiguilles, celles-ci doivent être manipulées avec un soin particulier. réservé aux professionnels de santé.
What is the SERAMON (5/0) suture from Serag-Wiessner?
The SERAMON suture from Serag-Wiessner is a synthetic, monofilament, and strictly non-absorbable surgical suture material. This medical device is distinguished by its polytetrafluoroethylene (PTFE) composition, a base material that provides high biocompatibility for soft tissues. Offered exclusively in an undyed (colorless) version, this thread features a smooth monofilament structure, limiting bacterial adherence and facilitating intratissue passage. The model referenced MEO101713 has a 5/0 (USP) calibre, suitable for procedures requiring high precision. This product is packaged in boxes of 24 sutures, each measuring 50 cm, ensuring sufficient length for tissue adaptation procedures or ligation in specialized surgery.
What are the clinical indications for this PTFE thread?
SERAMON is specifically intended for soft tissue adaptation or for performing ligations when a non-absorbable material is required by the practitioner. According to data from the manufacturer Serag-Wiessner, its use extends to various surgical procedures, including interventions involving the circulatory system and the central nervous system. In oral and implant surgery, PTFE threads are particularly valued for their dimensional stability. They can also serve as support threads or as a means of marking during complex protocols. The choice of this suture must be guided by the intrinsic characteristics of the PTFE material and the specific technical requirements of the planned surgical act, in accordance with the recommendations of the European Pharmacopoeia.
What are the technical characteristics of the DS-15 needle?
The DS-15 needle equipped on this SERAMON suture features precise geometric properties to optimize tissue penetration. The 'DS' prefix designates a 3/8 circle needle with a reverse cutting triangular point. This configuration is ideal for passing through dense or keratinized tissues without causing accidental tearing, as the cutting edge is located on the outer curvature. The number '15' indicates a needle length of 15 mm, offering an optimal compromise between maneuverability and control during flap closure or precision suturing. Manufactured from high-quality surgical steel, this needle is attached to a 50 cm thread of 5/0 calibre, meeting the needs of the most demanding surgeons.
What are the contraindications for the use of SERAMON suture?
The use of the SERAMON medical device is formally contraindicated in patients with known allergies to any of its components, particularly polytetrafluoroethylene (PTFE). Furthermore, the manufacturer specifies that there is not yet sufficient experience regarding the use of this specific material in certain highly specialized fields such as microsurgery, ophthalmology, or surgical interventions on peripheral nerves. It is imperative that the surgeon evaluates the benefit-risk ratio based on the patient's history and the specificities of the area to be sutured. Careful reading of the instructions for use is essential before any intervention to ensure patient safety and device efficacy.
What are the precautions related to the non-absorbable nature of the thread?
As a non-absorbable PTFE suture, SERAMON does not undergo degradation by hydrolysis or enzymatic action. It permanently retains its tensile strength in the tissues, which necessitates post-operative clinical monitoring. The practitioner must master the knotting techniques specific to synthetic monofilaments to ensure knot stability. Although PTFE is recognized for its flexibility and chemical inertness, requirements in terms of equipment and techniques vary according to clinical indications. It is crucial to take into account the physical properties of the thread, such as its diameter (compliant with the European Pharmacopoeia despite potential negligible deviations) and its lack of capillarity, to optimize soft tissue healing.
Who is the manufacturer and what standards are respected?
The SERAMON suture is manufactured by Serag-Wiessner GmbH & Co. KG, a company located in Naila, Germany. This medical device is classified as Class III, which corresponds to the highest level of regulatory requirement for surgical devices. It bears the CE1014 marking, certifying its compliance with current safety and performance requirements. Serag-Wiessner suture materials comply with the European Pharmacopoeia (Ph. Eur.) monograph relating to sterile non-absorbable suture materials (fila non resorbilia sterilia). This manufacturing rigor guarantees healthcare professionals a sterile, reliable, and perfectly documented product 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.
Specifications
| Manufacturer | Serag-Wiessner Suture Materials |
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