SERAFAST absorbable purple (4/0) HR-17 needle 70 CM box of 24 sutures - Serag & Wiessner (JO153276) - Delynov
Optimize mucosal closures with SERAFAST suture
This fast-absorbing synthetic monofilament ensures smooth handling and excellent tissue tolerance for your oral and implant surgeries.
- Packaging: Box of 24 devices.
- Gauge & Needle: 4/0 gauge with HR-17 needle (70 cm).
- Resorbability: Fast resorption (up to 2 weeks).
- Use: Soft tissue adaptation and ligatures in dental surgery.
The SERAFAST suture by Serag-Wiessner GmbH & Co. KG is a monofilament synthetic medical device designed for rapid absorption in oral, periodontal, and implant surgery.
- Material: Polyglycolide-Caprolactone (PGACL).
- Absorption: Rapid, 10 to 15 days.
- Needle: HR-17 (17 mm), 1/2 circle, round tip.
- Format: Thread length 70 cm, caliber 4/0 (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 prévuserafast® est un matériau de suture chirurgicale monofilament, synthétique et résorbable. il est composé d'un copolymère segmenté avec les composants de base glycolide et e-caprolactone. il est fourni teinté avec un colorant violet d+c no 2 (colour index n° 60725) ou non teinté. serafast® est disponible en différents calibres et longueurs. il est fourni avec différents types d'aiguilles en acier chirurgical. serafast® peut être associé à d'autres composants, comme un tube de guidage de suture. le matériel de suture est conforme à la monographie de la pharmacopée européenne (pe) «suture stérile synthétique résorbable monofilament (fila resorbilia synthetica monofilamenta sterilia)». serafast® est prévu pour l’adaptation des tissus mous ou pour les ligatures quand il est indiqué d’utiliser du matériel de suture résorbable rapidement (jusqu’à 2 semaines). lire attentivement la notice. avertissements et précautions : contre-indications serafast® ne doit pas être utilisé lorsqu’une stabilité prolongée ou durable du matériel de suture est nécessaire, comme p. ex. lors de fixation d’implants synthétiques (valves cardiaques, etc.). serafast® n’est pas destiné à être utilisé dans le système cardio-vasculaire central ou le système nerveux central. 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. serafast® doit être utilisé avec prudence chez les patients présentant un retard de cicatrisation. comme tout corps étranger, le dispositif peut provoquer la formation de calculs quand il reste en contact prolongé avec des solutions contenant du sel (p. ex. dans les voies biliaires ou urinaires). pour les sutures sous tension ou nécessitant une plus grande résistance, il peut être nécessaire d’utiliser en plus un matériau de suture non résorbable ou d’appliquer des techniques d'immobilisation appropriées. dans le cas des sutures intracutanées, le matériel de suture, en particulier les nœuds, doit être placé le plus profondément possible. les instruments chirurgicaux doivent être manipulés avec précaution pour éviter d’endommager les fils. il ne faut pas plier les aiguilles ou les saisir en dehors de la zone recommandée pour éviter qu’elles se brisent. étant donné le risque d’infection inhérent aux piqûres d’aiguilles, celles-ci doivent être manipulées avec un soin particulier. il convient d'être prudent dans l'utilisation de sutures résorbables dans des tissus présentant une faible irrigation sanguine, car une extrusion de la suture et une résorption retardée sont possibles. l'utilisation des sutures résorbables peut s'avérer inappropriée chez les personnes âgées, dénutries ou affaiblies. les sutures cutanées qui restent en place plus de 7 jours peuvent provoquer une irritation locale et doivent être coupées ou retirées. réservé aux professionnels de santé.
What is SERAFAST absorbable violet suture (4/0)?
SERAFAST from the Serag-Wiessner brand is a synthetic, monofilament, and absorbable surgical suture material. This medical device is designed from a segmented copolymer integrating base components such as glycolide and e-caprolactone. Its monofilament structure offers a smooth surface, limiting traumatic passage through tissues. This specific model features a 4/0 (USP) calibre and a thread length of 70 cm. It is dyed violet with D+C No. 2 dye (Colour Index No. 60725) to ensure excellent visibility during surgical interventions. Compliant with the European Pharmacopoeia monograph regarding sterile synthetic absorbable monofilament sutures, this product guarantees precise handling for healthcare professionals.
What are the clinical indications for this Serag-Wiessner suture?
SERAFAST suture is specifically intended for soft tissue adaptation or for performing ligatures. Its use is indicated when it is necessary to use an absorbable suture material with fast kinetics, with a duration of action of up to 2 weeks. In oral and implant surgery, it is particularly suitable for situations requiring short-term tissue support. The choice of this material must imperatively take into account the specific characteristics of the device and the specific needs of the surgical technique employed. This Class III device is an essential tool for practitioners seeking a reliable suture for rapid initial healing phases, in accordance with the recommendations of the manufacturer Serag-Wiessner GmbH & Co. KG.
What are the technical characteristics of the HR-17 needle?
The HR-17 needle equipped with this SERAFAST suture possesses specific properties for delicate interventions. According to technical nomenclature, the 'HR' code designates a 1/2 circle round-bodied needle. This configuration is particularly indicated for deep sutures as well as for ligatures, allowing precise penetration without cutting through surrounding tissues. The number '17' indicates a length of 17 mm for the needle body. Manufactured from high-quality surgical steel, this needle is attached to a 70 cm thread of 4/0 calibre. The combination of this HR-17 needle with the SERAFAST monofilament thread allows for optimal maneuverability during tissue closure procedures in the oral zone.
What are the contraindications for the use of SERAFAST?
The use of SERAFAST presents several major contraindications defined by the manufacturer Serag-Wiessner. This device must never be used when prolonged or lasting stability of the suture material is required, as is the case for the fixation of synthetic implants (for example, heart valves). Furthermore, SERAFAST is not intended for use in the central cardiovascular system or the central nervous system. Its use is strictly prohibited in patients with a known allergy to any of its components, notably glycolide, e-caprolactone, or the violet dye. Careful reading of the instructions is essential before any use to ensure the product's suitability for the patient's clinical condition.
How does resorption occur and what are the precautions for use?
SERAFAST is a rapidly absorbable thread, whose tissue support effectiveness is intended for a period of up to 2 weeks. Being a synthetic polymer, its degradation occurs progressively within the body. Special precautions must be taken in patients presenting delayed healing, as the loss of the thread's tensile strength could interfere with the apposition of the wound edges. Like any foreign body, prolonged implantation of this suture material can lead to local irritation. It is recommended to choose the suture technique and material based on the specific clinical requirements of each case, taking into account that this monofilament is designed for rapid resorption.
Who is the manufacturer and what standards are met by this product?
This suture is manufactured by Serag-Wiessner GmbH & Co. KG, a company based in Naila, Germany. The product carries the CE1014 marking, certifying its compliance with European safety and performance requirements. As a Class III medical device, it meets the strictest standards in force for surgical implants. The material complies with the European Pharmacopoeia (EP) monograph entitled "Sterile synthetic absorbable monofilament suture (Fila resorbilia synthetica monofilamenta sterilia)". Each box contains 24 sterile sutures under reference JO153276, guaranteeing dental surgeons and implantologists a high-tech product respecting international regulatory standards.
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 |
| Tags | |
|---|---|
| Tags | |