Gums Knife Goldman-Fox - Helmut Zepf (24.437.03)
The Couteau à Gencives Goldman-Fox - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.437.03.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Goldman-Fox gum knife?
The Goldman-Fox gum knife, referenced under code 24.437.03 by Helmut Zepf, is a manual surgical instrument specifically designed for the manipulation of soft tissues in oral surgery. Manufactured from medical stainless steel, this device belongs to the category of periodontics instruments. Its structure is optimized to provide a clean cut during gingival excision procedures. As a product of the Helmut Zepf Medizintechnik GmbH range, it meets the quality requirements for Class I devices. This instrument is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use as well as between each patient to ensure aseptic safety in the practice.
What are the clinical indications for this periodontics gingivectome?
This periodontics gingivectome is primarily indicated for gingivectomy and gingivoplasty procedures. In periodontal surgery, the goldman fox knife is used for the excision of hyperplastic gingival tissues or for reshaping gingival contours to restore physiological architecture. It also allows for the treatment of periodontal pockets by facilitating access to areas to be debrided. Its use is strictly reserved for qualified healthcare professionals, such as dental surgeons and periodontists, trained in periodontal plastic surgery techniques. The instrument must be inspected before each use to check for the absence of visible damage such as cracks or defects on the cutting edges that could compromise the surgical act.
What are the technical characteristics of the Goldman-Fox Helmut Zepf knife?
The Goldman-Fox knife (reference 24.437.03) is characterized by its manufacture in high-quality medical stainless steel, ensuring the robustness necessary for gingival incisions. This device is classified as a Class I instrument according to medical device regulations. Helmut Zepf Medizintechnik GmbH designs this tool to withstand repeated reprocessing cycles (cleaning, disinfection, and sterilization), although no maximum limit of cycles is defined due to its durable design. It is imperative to check compatibility with other products and cleaning solutions used in the practice. The cutting edges must remain perfectly sharp; any instrument showing signs of wear or breakage must be immediately removed from clinical use.
What are the contraindications for the use of this instrument?
The main contraindication for the use of the Goldman-Fox gum knife lies in the patient's known hypersensitivity or intolerance to metals, particularly medical stainless steel. A hypersensitivity reaction can be triggered upon contact between the instrument and the tissues. If such a reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken. Furthermore, the use of the instrument is contraindicated if it shows visible damage, cracks, or marked wear on the active parts. The manufacturer Helmut Zepf emphasizes that the use of damaged products presents a risk to patient safety and treatment efficacy.
What are the maintenance and sterilization precautions?
As it is a non-absorbable and reusable instrument, the Goldman-Fox Helmut Zepf knife requires a rigorous reprocessing protocol. All instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. The process must be complete to ensure the elimination of any biological residue. Before each use, the practitioner must perform a meticulous visual inspection to detect any defects on the cutting edges or the body of the instrument. Since Helmut Zepf products are delivered non-sterile, the responsibility for sterilization lies with the healthcare professional. Compliance with these safety instructions is essential to maintain the integrity of the stainless steel and extend the operational life of the device.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This gum knife is a Class I medical device, compliant with the regulatory requirements in force for manual dental instruments. The manufacturer ensures the traceability and quality of its products through rigorous manufacturing processes. As a Class I instrument, it meets the safety and performance standards applicable to non-invasive or invasive medical devices for temporary use. Professionals can refer to the manufacturer's instructions for cleaning and sterilization to ensure continuous compliance with hospital hygiene and dental practice standards.
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Specifications
| Manufacturer | Helmut Zepf |
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