SERALON non-absorbable blue (5/0) DS-18 needle of 75 CM box of 24 sutures - Serag & Wiessner (VO103414) - Delynov
The SERALON 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: Polyamide (Nylon).
- Type: Non-absorbable (suture removal required after healing).
- Needle: DS-18 (18 mm), 3/8 circle, triangular reverse cutting tip.
- Format: Thread length 75 cm, caliber 5/0 (USP).
- Packaging: Box of 24 single-use sterile sutures.
- Compliance: Medical device Class IIb, CE marking CE1014.
- Manufacturer: Serag-Wiessner GmbH & Co. KG.
What is the blue SERALON (5/0) suture thread?
SERALON from the brand Serag-Wiessner is a synthetic and non-absorbable surgical suture material. It is composed of polyamide (nylon) and features a monofilament structure. This technical configuration is particularly valued in surgery because it offers a smooth surface that limits bacterial adhesion and facilitates sliding through tissues. This 5/0 gauge thread is colored blue using phthalocyanine to ensure excellent visibility in the surgical field. It is packaged in boxes of 24 sterile sutures, each thread measuring 75cm, which is ideal for oral surgery and implantology procedures requiring high precision.
What are the clinical indications for this Serag-Wiessner suture?
SERALON is indicated for soft tissue suturing where a non-absorbable suture is required. In daily practice, this ophthalmic and dental suture thread is used for flap closure, periodontal surgeries, and implant procedures. Its non-absorbable nature makes it a relevant choice when the practitioner wishes to maintain stable tension during the initial healing phase. Although polyamide is an inert synthetic material, it should be noted that it can be used in ophthalmic surgery subject to compliance with specific precautions related to this discipline. This device meets the requirements of the European Pharmacopoeia for sterile non-absorbable sutures.
What are the technical characteristics of the DS-18 needle?
The DS-18 needle mounted on this SERALON suture has specific characteristics for firm tissues. The code 'DS' means it is a 3/8 circle needle with a reverse cutting triangular tip. This geometry is designed to pass through dense tissues, such as keratinized gingiva, without risking tearing the flap edge, as the cutting base is oriented towards the outside of the curvature. The figure 18 indicates a needle body length of 18 mm. This dimension, combined with the 5/0 gauge of the thread, offers an optimal balance between fineness for micro-surgery and mechanical strength for standard approximation sutures.
What are the contraindications for the use of SERALON?
The use of SERALON by Serag-Wiessner presents strict contraindications defined by the manufacturer. It must never be used for procedures involving direct contact with the heart, the central circulatory system, or the central nervous system. Furthermore, its use is prohibited in patients with a known allergy to polyamide or to the dyes used (phthalocyanine blue). Another important limitation concerns very long-term stability: although classified as non-absorbable, polyamide may undergo a progressive loss of tensile strength in the body over time. Consequently, it must not be used when permanent and indefinite stability of the suture material is essential.
What are the precautions related to the non-absorbable nature of the thread?
As SERALON is a non-absorbable monofilament thread, it requires a specific knotting technique. Due to the high elasticity and shape memory of polyamide monofilament threads, the manufacturer Serag-Wiessner recommends performing one or two additional knots compared to a braided thread to guarantee the security and strength of the suture. Unlike absorbable materials, this thread must be manually removed once clinical healing is achieved. Vigilance is also required in areas in contact with saline solutions (biliary or urinary tracts) where, like any foreign body, it could promote the formation of calculi, although this risk is marginal in oral surgery.
Who is the manufacturer and what standards are met by this product?
This medical device is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized company based in Naila, Germany. The product complies with the strictest European safety and performance standards, benefiting from a CE1014 marking. It is classified as a Class IIb medical device according to current regulations. Manufacturing complies with the current European Pharmacopoeia monograph relative to sterile non-absorbable sutures (fila non resorbiliasterilia). The reference VO103414 guarantees product traceability, ensuring dental surgeons and implantologists the use of reliable and certified material for their operative procedures.
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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