Scalpel Handle No. 3 Graduated - Hu-Friedy - Delynov
The Manche de bistouri #3 gradué - 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 #3 graduated scalpel handle?
The #3 graduated scalpel handle, designed by the manufacturer Hu-Friedy, is a manual surgical instrument intended to receive interchangeable scalpel blades. Its structure is specifically adapted to the needs of oral surgery, offering a stable grip for precision incisions. This model is distinguished by the integration of graduations on its body, allowing for rapid and direct measurement at the surgical site. As a Class I medical device, it meets the manufacturing requirements of Hu-Friedy Mfg. Co., LLC, guaranteeing a reliable instrument for soft tissue cutting procedures.
What are the clinical indications?
This scalpel handle is indicated for all interventions requiring clean and controlled incisions of soft tissues in the oral environment. In implant surgery, it facilitates the opening of full-thickness or partial-thickness flaps. In periodontology, it is used for gingivectomies, gingivoplasties, or the harvesting of epithelial-connective tissue grafts. The presence of graduations on the Hu-Friedy instrument helps the surgeon calibrate incisions or verify the depth of certain sulci, making this tool particularly useful during surgical planning phases where dimensional measurement is critical to treatment success.
What are the technical characteristics?
The Hu-Friedy #3 graduated scalpel handle features standard compatibility with type #10, #11, #12, and #15 blades, commonly used in dentistry. Its design ensures a rigid fixation of the blade to avoid any lateral play during the incision. The major technical element lies in its millimeter marking, engraved on the handle, which serves as a supplementary ruler during the procedure. Manufactured by Hu-Friedy Mfg. Co., LLC, this Class I instrument is designed to undergo repeated sterilization cycles without alteration of its mechanical properties or the readability of its graduations, respecting the brand's quality standards.
What are the contraindications for use?
Contraindications related to the use of the Hu-Friedy #3 graduated scalpel handle mainly concern use by unqualified personnel, as this instrument is strictly reserved for healthcare professionals trained in surgical techniques. Although the raw MDR text does not list specific medical contraindications related to the material, it is imperative not to use the instrument in the event of a visible defect in the blade fixation mechanism, which could compromise the safety of the patient and the practitioner. Careful reading of the instructions before use is required to comply with the safety protocols established by the manufacturer.
What are the maintenance and handling precautions?
As a non-absorbable and reusable instrument, the Hu-Friedy #3 graduated scalpel handle requires a rigorous decontamination and sterilization protocol after each intervention. The used blade should be removed carefully using an appropriate extractor to avoid any risk of percutaneous injury. Cleaning must eliminate all organic debris, particularly in the blade fixation area and at the level of the graduations. Compliance with the sterilization cycles recommended by Hu-Friedy is essential to maintain the integrity of the instrument and ensure the asepsis necessary for oral and implant surgery procedures.
Who is the manufacturer and what standards are respected?
The #3 graduated scalpel handle is manufactured by Hu-Friedy Mfg. Co., LLC, headquartered in Chicago, USA. This medical device is listed as Class I, in accordance with current medical device regulations. Manufacturing by Hu-Friedy ensures compliance with high quality standards for surgical instrumentation. Although specific CE marking is not detailed in the source data, the instrument is intended exclusively for professional use in dental offices or hospital environments. Practitioners must refer to the instructions provided by the manufacturer to ensure use in accordance with regulatory and clinical requirements.
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