SERALENE non-absorbable blue (5/0) DSS-13 needle 50 CM box of 24 sutures - Serag & Wiessner (LO10171L) - Delynov
Product features
The SERALENE 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 suture chirurgicale, monofilament, synthétique et non résorbable. le matériau de base du fil est le polyfluorure de vinylidène. seralene® est teinté en solvent blue, colour index nº 61568..
- Type: Non-absorbable (suture removal required after healing).
- Needle: DSS-13 (13 mm), 3/8 circle, atraumatic triangular tip.
- Format: Thread length 50 cm, caliber 5/0 (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/germany - usage prévu : suture surgical : description et emploi prévu seralene® est un matériau de suture chirurgicale, monofilament, synthétique et non résorbable. le matériau de base du fil est le polyfluorure de vinylidène. seralene® est teinté en solvent blue, colour index nº 61568. seralene® est disponible en différents calibres et longueurs. il est fourni avec différents types d'aiguilles en acier chirurgical ou sans aiguille. il peut être associé à d'autres composants, comme un tube de guidage de suture. seralene® peut contenir des compresses destinées à renforcer les structures corporelles. les matériaux de suture à base de polyfluorure de vinylidène sont conformes aux exigences sous-jacentes de la monographie de la pharmacopée européenne «sutures stériles non-absorbables» (fila non resorbilia sterilia). seralene® est conçu pour le rapprochement des tissus mous ou pour les ligatures nécessitant l‘utilisation de fil de suture non résorbable, y compris l'utilisation au niveau des systèmes circulatoire et nerveux centraux, ainsi qu'en microchirurgie et en ophtalmologie. les fils de fluorure en polyvinyle peuvent également servir de fils de soutien et de moyen de marquage. - lire attentivement la notice. avertissement 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 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 tous les corps étrangers, le dispositif peut provoquer la formation de calculs lors d'un contact prolongé avec les voies biliaires ou urinaires. l'utilisation de mesures auxiliaires adaptées est recommandée pour les sutures dans des tissus infectés. les instruments chirurgicaux doivent être maniés avec soin pour éviter d'endommager la suture. les aiguilles peuvent se casser si on les plie ou si on les tient en dehors de la zone recommandée. étant donné le risque d’infection qu’entraînent les piqûres d’aiguilles, celles-ci doivent être manipulées avec le maximum de précaution. – dispositif médical - réservé aux professionnels de santé.
What is SERALENE non-absorbable blue (5/0) suture?
SERALENE from the brand Serag-Wiessner is a synthetic, non-absorbable surgical suture material. This device is presented as a monofilament designed from polyvinylidene fluoride, a base material ensuring a homogeneous and smooth structure. To ensure optimal visibility during surgical procedures, the thread is dyed blue (solvent blue, colour index nº 61568). This specific model has a USP 5/0 calibre and a thread length of 50 cm. As a monofilament, it offers excellent glide through tissues, thereby reducing tissue trauma during suture passage. This product is delivered in a box of 24 sterile sutures, meeting the requirements of practitioners for procedures requiring high precision.
What are the clinical indications for SERALENE?
SERALENE is designed for soft tissue approximation or for performing ligatures requiring the use of non-absorbable suture thread. Its properties make it particularly suitable for interventions in the central circulatory and nervous systems, as well as in microsurgery and ophthalmology. In oral surgery and implantology, it is used for the management of delicate tissues and thin membranes. The manufacturer Serag-Wiessner also specifies that polyvinyl fluoride threads can serve as stay sutures or as a means of marking. Thanks to its non-absorbable nature, it maintains constant tensile strength, which is crucial for body structures requiring long-term support or in specific healing contexts.
What are the technical characteristics of the DSS-13 needle?
The SERALENE suture (LO10171L) is equipped with a technical needle referenced DSS-13. According to Serag-Wiessner specifications and Delynov nomenclature, the DSS code designates a 3/8 circle needle equipped with an atraumatic reverse cutting triangular point. This configuration is specifically designed to facilitate penetration into dense tissues while minimizing the risk of tearing thin mucosa or delicate tissues. The number 13 indicates a needle length of 13 mm. Manufactured from high-quality surgical steel, this needle allows for precise control of the suture path, meeting the requirements of microsurgery and oral surgical interventions where the workspace is restricted and precision is paramount.
What are the contraindications for the use of this suture?
The use of the SERALENE device presents certain limitations and contraindications defined by the manufacturer Serag-Wiessner GmbH & Co. KG. This device must absolutely not be used in patients with known or suspected allergies to any of its components, notably to polyvinylidene fluoride or the solvent blue dye (nº 61568). As with any implanted foreign body, prolonged contact with the biliary or urinary tracts can cause the formation of calculi. It is imperative that the practitioner adapts the choice of material and suture techniques based on clinical indications and the specific characteristics of the material. Careful reading of the instructions for use is essential before any use to guarantee patient safety.
How is a non-absorbable suture like SERALENE managed?
As SERALENE is a non-absorbable material, it does not undergo a degradation process by hydrolysis or enzymatic action. It retains its physical integrity and tensile strength indefinitely after implantation, unless it is manually removed by the surgeon. This characteristic imposes specific precautions when performing knots to ensure maximum security, given the smooth surface of the polyvinylidene fluoride monofilament. Requirements in terms of suture techniques vary according to clinical indications. The practitioner must take into account that this thread will remain in the organism as a permanent foreign body, unless the procedure provides for its removal after the initial soft tissue healing phase.
Who is the manufacturer and what standards are respected?
SERALENE suture is manufactured by Serag-Wiessner GmbH & Co. KG, whose headquarters are located in Naila, Germany. This medical device is classified as Class III, which corresponds to the highest risk level for implantable devices, and carries the CE1014 marking. The quality and safety of the product are guaranteed by its compliance with the requirements of the European Pharmacopoeia monograph relating to "sterile non-absorbable sutures" (fila non resorbilia sterilia). Compliance with these strict standards ensures dental surgeons and implantologists a reliable, sterile, and high-performance material for their most complex interventions. Each box contains 24 ready-to-use units, identified by the technical reference LO10171L.
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.
Further reading on Delynov
- The Scientific Breakthrough Redefining Surgical Sutures: A Bulwark Against Infection
In the world of surgery, every detail is critical to ensuring procedural success and patient healing. One of the most closely monitored risks remains surgical site infection… - Innovation in Resorbable Sutures: A Cellulose and Propolis-Based Composite for Oral Surgery
Introduction Suture material, the earliest known type of implant in history, is a fundamental component of surgery. An ideal material must combine several demanding properties: high tensile strength, biocompatibility, and antimicrobial activity. - Soft Tissue Management: Apical Mattress Suture Increases Keratinized Gingiva Thickness
Introduction The quality and quantity of peri-implant soft tissues are determining factors for long-term treatment success, influencing hygiene maintenance, the...
Specifications
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