SERAMON non-absorbable colorless (4/0) DS-18 needle 50 CM box of 24 sutures - Serag & Wiessner (MEO151714) - 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-18 (18 mm), 3/8 circle, triangular reverse cutting tip.
- Format: Thread length 50 cm, caliber 4/0 (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 non-absorbable SERAMON (4/0) from Serag-Wiessner?
SERAMON is a synthetic, monofilament, non-absorbable surgical suture material designed by Serag-Wiessner. This medical device is distinguished by its full composition of polytetrafluoroethylene (PTFE), a base material recognized for its technical properties in surgery. Offered exclusively in a non-colored (colorless) version, this thread features a monofilament structure that limits bacterial adherence and facilitates sliding through tissues. The model referenced MEO151714 has a 4/0 (USP) calibre and a thread length of 50 cm. It meets the strict requirements of the European Pharmacopoeia regarding non-absorbable sterile suture materials (fila non resorbilia sterilia), ensuring optimal quality for demanding surgical interventions.
What are the clinical indications for PTFE SERAMON?
SERAMON is specifically intended for soft tissue adaptation or for ligation in cases where a non-absorbable suture material is indicated. Its clinical applications are broad, including use in the circulatory system and the central nervous system. In surgical practice, PTFE threads like SERAMON can also serve as support threads or as a means of marking. This device is particularly suitable for situations requiring high biocompatibility and prolonged mechanical stability, as the material undergoes no degradation by tissue enzymes. Surgeons use it to ensure precise coaptation of wound edges while benefiting from the inherent flexibility of polytetrafluoroethylene.
What are the technical characteristics of the DS-18 needle?
The SERAMON suture (MEO151714) is equipped with a DS-18 needle made of high-quality surgical steel. According to technical nomenclature, the code 'DS' designates a 3/8 circle needle equipped with a triangular reverse cutting tip. This specific geometry is ideal for passing through dense tissues without causing undesirable tissue tearing, as the cutting edge is located on the outer curvature of the needle. The number '18' indicates a needle body length of 18 mm. This configuration is particularly relevant for practitioners seeking precise and secure penetration during soft tissue closure procedures, offering reliable handling and excellent resistance to torsion.
What are the contraindications for the use of this suture?
The use of the SERAMON device presents certain limits and contraindications defined by the manufacturer Serag-Wiessner GmbH & Co. KG. The device must absolutely not be used in patients with known allergies to any of its components, notably polytetrafluoroethylene (PTFE). Furthermore, the manufacturer specifies that there is not yet sufficient experience regarding the use of this specific material in the fields of microsurgery, ophthalmology, or during surgical interventions on peripheral nerves. The choice of suture material must always take into account the specific characteristics of the product and the technical requirements of the planned surgical act. Careful reading of the instructions is imperative before any clinical use.
How does the SERAMON suture behave over time (non-absorbable)?
As SERAMON is a non-absorbable PTFE suture, it undergoes no loss of tensile strength and is not degraded by the body's hydrolysis or enzymolysis processes. Unlike absorbable threads, it remains structurally stable over the long term, which requires specific management during the post-operative phase. Its monofilament nature reduces the risks of capillarity and plaque accumulation, a major advantage for maintaining hygiene at the surgical site. Precautions for use include a knotting technique adapted to the sliding properties of PTFE to ensure knot security. This thread is delivered sterile and must be handled according to standard aseptic protocols.
Who is the manufacturer and what standards are respected by this product?
The SERAMON suture is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. This medical device is classified as Class III, which corresponds to the highest level of safety and control for surgical devices. It benefits from the CE1014 marking, certifying its compliance with European regulatory requirements (MDR). The product complies with the current monograph of the European Pharmacopoeia (Ph. Eur.) relating to non-absorbable sterile suture materials. Each box contains 24 ready-to-use sutures, ensuring optimal traceability and safety for healthcare facilities and practices specialized in oral surgery and implantology.
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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