Gardner Bone Chisel #5 with #524 Handle - Hu-Friedy - Delynov
The Ciseau à os Gardner #5 manche #524 - Hu-Friedy is a medical device manufactured by Hu-Friedy Mfg. Co., LLC.
- Compliance: Medical device Class I.
- Manufacturer: Hu-Friedy Mfg. Co., LLC.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Hu-Friedy |
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What is the Hu-Friedy Gardner #5 bone chisel?
Le ciseau à os Gardner #5, associé au manche #524, est un instrument chirurgical de haute qualité. Cet instrument est spécifiquement conçu pour les interventions de chirurgie osseuse fine. Sa structure se compose d'une partie travaillante biseautée et d'un manche ergonomique référencé #524, permettant au praticien d'exercer une force contrôlée lors de la coupe ou du remodelage des tissus osseux. En tant qu'instrument de la catégorie INSTRU, il répond aux exigences de fabrication d'un fabricant reconnu dans le secteur de la chirurgie orale, garantissant une robustesse adaptée aux contraintes de l'ostéotomie.
What are the clinical indications for this instrument?
This device is indicated for various oral and maxillofacial surgery procedures. The Gardner bone chisel is primarily used for bone tissue resection, alveoloplasty, or the harvesting of autogenous bone chips during grafting. In implantology, it facilitates the preparation of the recipient site by allowing for the regularization of alveolar ridges or the elimination of exostoses that interfere with the placement of implants or prostheses. Its use is strictly reserved for qualified healthcare professionals, in accordance with Hu-Friedy manufacturer guidelines.
What are the technical characteristics of the #524 handle?
The Gardner #5 bone chisel is mounted on a specific handle bearing the reference #524 from Hu-Friedy. This handle is designed to provide a stable and secure grip, essential when applying a surgical mallet or significant manual pressure. The connection between the handle and the chisel blade is optimized to transmit striking energy axially, thereby minimizing vibrations and maximizing the precision of the surgical gesture. The overall design complies with Class I standards for medical devices.
What are the contraindications for the use of this bone chisel?
According to information provided by Hu-Friedy Mfg. Co., LLC, the use of this instrument is subject to standard clinical indications and contraindications related to bone surgery. Although the source document does not list specific pathologies prohibiting its use, it is imperative that the practitioner evaluates the patient's general health status before any invasive intervention. The use of this instrument is contraindicated for any application outside of the surgery for which it was designed, or by personnel not trained in osteotomy techniques.
What are the maintenance and handling precautions?
As a non-resorbable instrument intended for repeated use after sterilization, the Gardner bone chisel requires rigorous maintenance. Before any use, it is essential to carefully read the instructions provided by Hu-Friedy. Cleaning must be performed immediately after the surgical act to prevent the encrustation of organic debris. The practitioner must check the integrity of the cutting edge and the absence of corrosion before each sterilization cycle. Careful handling is required to preserve the geometry of the #5 bevel and guarantee the longevity of the instrument.
Who is the manufacturer and what standards are respected?
Le ciseau à os Gardner #5 avec manche #524 est fabriqué par Hu-Friedy Mfg. Co., LLC, situé au 3232 N. Rockwell St. Chicago, USA. Ce dispositif médical est classé en Classe I, ce qui correspond aux instruments chirurgicaux réutilisables selon la réglementation en vigueur. Ce produit est réservé exclusivement aux professionnels de santé. Le respect des protocoles de nettoyage et de stérilisation recommandés par Hu-Friedy est essentiel pour maintenir la conformité de l'instrument aux exigences de sécurité et de performance clinique attendues pour cette catégorie de dispositifs.
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