SERAFIT absorbable purple (6/0) HR-10 needle of 70 CM box of 24 sutures - Serag & Wiessner (6O073237) - Delynov
The SERAFIT suture by Serag-Wiessner GmbH & Co. KG is a monofilament synthetic medical device designed for progressive absorption in oral, periodontal, and implant surgery.
- Material: de suture multifilament tressé, synthétique, résorbable. il est composé de l'homopolymère de l'acide glycolique. serafit® peut être recouvert de stéarate de calcium avec polycaprolactone ou d'acide polyglycolique/polyligatures sont un type particulier de suture dont l'objectif est de fermer des organes creux..
- Absorption: Rapid, progressive absorption by hydrolysis.
- Needle: HR-10 (10 mm), 1/2 circle, round tip.
- Format: Thread length 70 cm, caliber 6/0 (USP).
- Packaging: Box of 24 single-use sterile sutures.
- Compliance: Medical device Class III, CE marking CE1014.
- Manufacturer: Serag-Wiessner GmbH & Co. KG.
What is the SERAFIT violet absorbable suture (6/0)?
SERAFIT from the brand Serag-Wiessner is a braided and synthetic absorbable suture material. This medical device is composed of a homopolymer of glycolic acid, structured as a multifilament to guarantee excellent flexibility and knot security. With a 6/0 calibre, this thread is colored violet for increased visibility in the operative field. According to the specifications of the manufacturer Serag-Wiessner GmbH & Co. KG, the thread can be coated with calcium stearate with polycaprolactone or polyglycolic acid to optimize trans-tissue passage. It is packaged in boxes of 24 sutures, each thread measuring 70cm in length.
What are the clinical indications for this device?
The intended use of SERAFIT by the manufacturer Serag-Wiessner concerns general surgical suturing. In oral and implant surgery, this braided absorbable suture is particularly indicated for ligatures and the closure of hollow organs. Its 6/0 calibre is suitable for interventions requiring high precision and fine management of soft tissues. The choice of this material must take into account the in-vivo characteristics of the thread, notably its progressive loss of strength, which makes it ideal for tissues whose healing does not require permanent mechanical support beyond the initial phase of tissue repair.
What are the technical characteristics of the HR-10 needle?
Reference 6O073237 is equipped with an HR-10 needle. According to the technical nomenclature, the code 'HR' designates a 1/2 circle round-bodied needle. This needle profile is specifically indicated for deep sutures and ligatures, allowing precise penetration without excessive cutting effect on delicate tissues. The number '10' indicates a needle body length of 10 mm. This compact configuration is perfectly adapted to the restricted spaces of the oral cavity, offering the surgeon optimal maneuverability during micro-surgery or periodontology procedures requiring a small-sized needle.
What are the contraindications for the use of SERAFIT suture?
In accordance with the warnings from the manufacturer Serag-Wiessner, SERAFIT suture must not be used in clinical situations where prolonged or long-term mechanical stability of the material is required. It is also contraindicated in patients with a known allergy to any of the components, including glycolic acid, calcium stearate, or polycaprolactone. Furthermore, its use may be inadequate in tissues with low blood supply, as this could lead to suture extrusion or delayed resorption. The user must master appropriate surgical techniques before any application.
How does resorption occur and what are the precautions?
SERAFIT is degraded by a process of hydrolysis in the tissues, transforming the polymer into glycolic acid which is then metabolized by the body. The loss of breaking strength is progressive: it loses approximately 60% of its initial value after 14 days (in vitro data). Total resorption of the thread mass is generally completed after approximately 90 days in-vivo. Particular caution is recommended in patients with delayed healing. It is essential to read the instructions carefully as technical requirements vary according to the clinical indication and the resorption characteristics of the chosen material.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized manufacturer located in Naila, Germany. The SERAFIT violet absorbable (6/0) product benefits from CE1014 marking, guaranteeing its compliance with current European requirements. Due to its nature as an absorbable implantable device, it is classified as Class III, the highest regulatory safety level. Each box of 24 sutures meets rigorous manufacturing standards, ensuring practitioners a reliable material for their daily surgical interventions in office or hospital settings.
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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