SERALENE non-absorbable blue (5/0) DSS-15 needle of 50 CM box of 24 sutures - Serag & Wiessner (LO10171T) - Delynov
Optimize your tissue closures with SERALENE suture
SERALENE is a non-resorbable synthetic monofilament offering optimal tissue glide and long-lasting stability for your oral surgery procedures.
- Packaging: Box of 24 devices.
- Gauge & Needle: 5/0 gauge with DSS-15 needle (50 cm).
- Resorbability: Non-resorbable (Polyvinylidene fluoride).
- Use: Soft tissue approximation and ligatures in implantology.
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-15 (15 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: 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/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 is a synthetic, monofilament, and non-absorbable surgical suture material developed by the brand Serag-Wiessner. Its monofilament structure is composed of polyvinylidene fluoride, a polymer recognized for its stability and biocompatibility. Dyed blue (solvent blue, colour index nº 61568) for optimal visibility during interventions, this thread has a 5/0 (USP) calibre and a total length of 50 cm. In accordance with the European Pharmacopoeia monograph on sterile non-absorbable sutures, SERALENE offers a smooth surface limiting bacterial adherence and facilitating gliding through tissues. This device is particularly suitable for procedures requiring constant mechanical strength over time.
What are the clinical indications for this Serag-Wiessner suture?
SERALENE suture is designed for soft tissue approximation or for performing ligatures requiring the use of a non-absorbable thread. Its clinical applications are vast, including microsurgery, ophthalmology, as well as interventions on the central circulatory and nervous systems. In oral and implant surgery, it is indicated for flap closure and the maintenance of delicate tissues. Polyvinylidene fluoride threads can also be used as support threads or as a means of marking. The choice of this suture material must be made by the practitioner taking into account the specific characteristics of the product and the technical requirements of the surgical act.
What are the technical characteristics of the DSS-15 needle?
The needle equipping reference LO10171T is a DSS-15 needle made of surgical steel. According to technical nomenclature, the DSS code corresponds to a 3/8 circle curvature needle equipped with an atraumatic reverse cutting triangular point. This configuration is specifically designed for the penetration of delicate tissues and thin mucous membranes, minimizing tissue trauma during thread passage. The number 15 indicates a needle body length of 15 mm. This combination of the SERALENE thread 5/0 calibre and the precision of the DSS-15 needle allows for rigorous handling, essential for precision sutures in aesthetic or functional areas.
What are the contraindications for the use of SERALENE?
The use of the SERALENE medical device is strictly contraindicated in patients with known allergies to any of its components, notably polyvinylidene fluoride or the blue dye (solvent blue nº 61568). As with any foreign body, the manufacturer Serag-Wiessner specifies that prolonged contact of the suture with the biliary or urinary tracts may promote the formation of calculi. It is the surgeon's responsibility to assess the potential risks based on the patient's medical history and the location of the suture. Compliance with asepsis protocols and appropriate suturing techniques is imperative to limit the risk of post-operative complications.
How does this non-absorbable suture behave and what are the precautions?
As a non-absorbable suture, SERALENE maintains its structural integrity and tensile strength indefinitely after implantation, not undergoing hydrolysis or enzymatic degradation processes. This characteristic requires particular vigilance when performing knots to ensure closure security. The practitioner must adapt their suturing technique to the physical properties of the polyvinylidene fluoride monofilament. It is recommended to carefully read the instructions for use provided by the manufacturer. Precautions must be taken to avoid damaging the thread surface with surgical instruments, which could compromise its tensile strength.
Who is the manufacturer and what standards are respected by this device?
This suture is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. The product benefits from a high level of regulatory safety, being classified as a Class III medical device. It bears the CE1014 marking, guaranteeing its compliance with the safety and performance requirements of the European Medical Device Regulation (MDR). The base material respects the European Pharmacopoeia standards for non-absorbable threads (fila non resorbilia sterilia). The box contains 24 sterile sutures, each packaged to maintain asepsis until its use in the operating theater or dental office.
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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