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SERAMON non-absorbable clear (4/0) DS-15 needle 50 CM box of 24 sutures - Serag & Wiessner (MEO151713) - Delynov

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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 4/0 (usp).
  • Packaging: Box of 24 single-use sterile sutures.
  • Compliance: Class III 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 :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.


Medical devices intended for healthcare professionals. Classes I, II and III. Carefully read the instructions in the leaflets and user manuals.

448.31 € 448.31 EUR 448.31 € Tax Included 574.45 €

448.31 € Tax Included 574.45 €

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Sutures

What is the SERAMON non-absorbable suture (4/0)?

The SERAMON suture, developed by Serag-Wiessner, is a high-performance synthetic surgical suture material. It is a non-absorbable monofilament designed from polytetrafluoroethylene (PTFE). This device is distinguished by its monofilament structure which limits capillarity and the risk of bacterial colonization, a major asset in oral surgery. Offered exclusively in a non-colored (colorless) version, this thread has a USP 4/0 calibre, suitable for procedures requiring high precision. Its PTFE composition gives it excellent biocompatibility and fluid handling through soft tissues. This specific packaging (MEO151713) includes a box of 24 sterile sutures, each measuring 50 cm in length, meeting the requirements of practitioners for tissue adaptation or ligation interventions.

What are the clinical indications for SERAMON in surgery?

SERAMON from Serag-Wiessner is indicated for soft tissue adaptation or for performing ligatures when a non-absorbable suture material is required. Its physical properties allow for extensive use, including in sensitive areas such as the circulatory system and the central nervous system. In daily practice, these PTFE threads can also serve as support threads or as a means of surgical marking. Although the manufacturer specifies that experience is still insufficient in microsurgery, ophthalmology, or for interventions on peripheral nerves, its stability and chemical inertness make it a relevant choice for dental surgeons and implantologists seeking airtight and durable closure of flaps, particularly during bone regeneration procedures or implant placement.

What are the technical characteristics of the DS-15 needle?

The SERAMON suture (MEO151713) is equipped with a DS-15 type technical needle. According to the reference nomenclature, the 'DS' code designates a 3/8 circle needle equipped with a triangular reverse cutting point. This configuration is specifically designed to penetrate dense and fibrous tissues with minimal resistance, while avoiding involuntary tissue tearing thanks to its cutting edge positioned on the outer curvature. The number '15' indicates a needle body length of 15 mm. This dimension, combined with a 50 cm thread, offers an optimal balance for interventions in restricted areas, allowing the surgeon precise and secure handling when passing sutures through the oral mucosa.

What are the contraindications for the use of this PTFE suture?

The use of the SERAMON device is strictly contraindicated in patients with known allergies to any of its components, notably polytetrafluoroethylene (PTFE). The manufacturer Serag-Wiessner also emphasizes that the choice of suture material must imperatively take into account the specific characteristics of the product and the needs of the clinical indication. To date, clinical data are considered insufficient to recommend its use in microsurgery, ophthalmic surgery, or for interventions on peripheral nerves. It is the responsibility of the practitioner to carefully read the instructions for use and evaluate the benefit-risk ratio according to the surgical technique employed, as requirements vary considerably from one procedure to another.

How is a non-absorbable suture like SERAMON managed?

As SERAMON is a non-absorbable PTFE suture material, it does not undergo any degradation by hydrolysis or enzymatic proteolysis within the body. Unlike absorbable sutures, it retains its tensile strength indefinitely after implantation. This characteristic requires rigorous post-operative monitoring and generally necessitates a secondary intervention for the removal of sutures once soft tissue healing is achieved. During placement, the surgeon must pay particular attention to the knotting technique to guarantee the stability of the knots, as PTFE is a very smooth material. However, its monofilament structure ensures atraumatic removal and limits the accumulation of dental plaque along the thread during the healing phase.

Who is the manufacturer and what standards are respected by this device?

SERAMON 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 regulatory requirement for surgical devices. It benefits from the CE1014 marking, certifying its compliance with European safety and performance requirements. Furthermore, Serag-Wiessner suture materials comply with the specifications of the current edition of the European Pharmacopoeia (Ph. Eur.) monograph relating to sterile non-absorbable suture materials (fila non resorbilia sterilia). Only negligible deviations concerning the thread diameter compared to the monograph may be observed, thus guaranteeing a product of constant high quality for operating theaters.


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.

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