SERALON non-absorbable blue (4/0) needle DS-15 of 50 CM box of 24 sutures - Serag & Wiessner (VO151713) - 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-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: Medical device Class IIb, CE marking CE1014.
- Manufacturer: Serag-Wiessner GmbH & Co. KG.
What is the SERALON non-absorbable blue 4/0 suture?
SERALON is a synthetic, non-absorbable surgical suture material designed by Serag-Wiessner. It is composed of polyamide (nylon) and comes in the form of a monofilament thread. This smooth structure reduces tissue trauma during thread passage and limits the risk of bacterial colonization through capillarity. The USP 4/0 calibre is particularly suitable for oral surgery procedures requiring moderate tensile strength. Its blue coloration, obtained through phthalocyanine blue (color index no. 74160), ensures excellent visibility in the surgical field. This device is packaged in boxes of 24 sterile sutures of 50 cm in length, meeting the requirements of the European Pharmacopoeia for sterile non-absorbable sutures.
What are the clinical indications for this Serag-Wiessner device?
Although the general intended use is surgical suturing, this polyamide monofilament thread is commonly used in oral, periodontal, and implant surgery. Its non-absorbable nature makes it ideal for wound closure where temporary mechanical stability is required before manual removal of the stitches. Due to its synthetic composition, it is indicated for procedures where a minimal inflammatory reaction is desired. However, the practitioner must adapt the choice of material according to the specific characteristics of the surgical site. It is important to note that this thread may cause stone formation in case of prolonged contact with saline solutions, such as in the biliary or urinary tracts, although this is less frequent in the oral sphere.
What are the technical characteristics of the DS-15 needle?
The needle identified by the code DS-15 has specific geometric features for surgery. The 'DS' prefix designates a 3/8 circle needle with a triangular reverse cutting tip. This configuration is specifically designed to pass through dense or keratinized tissues, such as the attached gingiva or the periosteum, without the risk of tearing towards the wound edge. The number '15' indicates a needle body length of 15 mm. This intermediate dimension offers an excellent compromise between maneuverability in the restricted spaces of the oral cavity and the ability to engage enough tissue for a secure suture. The combination of the 4/0 thread and this needle allows for rigorous precision during flap sutures.
What are the contraindications for the use of SERALON suture?
The use of SERALON manufactured by Serag-Wiessner GmbH & Co. KG is subject to several imperative restrictions. It is formally contraindicated for any use involving direct contact with the heart, the central circulatory system, or the central nervous system. Furthermore, due to a possible progressive loss of tensile strength within the body over the very long term, this thread should not be used when permanent or prolonged stability of the suture material is essential. Finally, its use is prohibited in patients with a known allergy to polyamide or the dyes used (phthalocyanine blue). The practitioner must systematically consult the instructions for use before employment to verify suitability with the patient's clinical profile.
What are the precautions related to the non-absorbable nature and the knots?
As SERALON is a non-absorbable thread, it requires a subsequent intervention for its removal once initial healing is achieved. Particular attention must be paid to the knotting technique. Due to the high elasticity and smooth surface of polyamide monofilament threads, especially in larger diameters, the manufacturer recommends making one or two additional knots compared to braided threads. This precautionary measure is essential to ensure the strength of the suture and prevent any knot slippage under the effect of tissue tension or peri-oral muscle movements. Handling must be precise to avoid damaging the monofilament structure with needle-holder instruments, which could weaken the thread.
Who is the manufacturer and what standards are respected?
This suture is produced by Serag-Wiessner GmbH & Co. KG, a recognized manufacturer based in Naila, Germany. The product carries the CE1014 marking, guaranteeing its compliance with European safety and performance requirements. It is classified as a Class IIb medical device. The suture material strictly complies with the current European Pharmacopoeia (EP) monograph regarding 'sterile non-absorbable sutures'. Each box contains 24 sterile units, identified under the technical reference VO151713. Compliance with these rigorous standards ensures dental surgeons and implantologists a reliable device for their daily interventions, combining industrial traceability and German manufacturing quality.
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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