Micro Needle Holder - Helmut Zepf (41.200.15TC) - Delynov

What is the Helmut Zepf Micro Needle Holder (41.200.15TC)?

The Helmut Zepf Micro Needle Holder, referenced under code 41.200.15TC, is a high-precision instrument specifically developed for the requirements of oral surgery. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device is intended for the firm gripping and guiding of suture needles. Its design allows for delicate handling, meeting the needs of practitioners seeking precision dental instrumentation for their daily procedures. As a Class I device, it meets the regulatory safety requirements for reusable surgical instruments, offering a reliable solution for soft tissue management.

What are the clinical indications for this surgery micro needle holder?

The intended use of the Helmut Zepf micro needle holder is strictly defined for holding and manipulating needles during surgical suturing. In clinical practice, it is particularly indicated during periodontal plastic surgery procedures, pre-implant surgeries, or extraction site closures. Its fine structure allows the surgeon to operate in restricted access areas with great agility. This plastic surgery instrument is a major ally for performing precise stitches, guaranteeing optimal coaptation of the wound edges, a determining factor for successful primary intention healing in the oral environment.

What are the technical characteristics of the 41.200.15TC instrument?

The Helmut Zepf 41.200.15TC Micro Needle Holder is distinguished by its manufacture in high-quality medical stainless steel. Although specific dimensions are not detailed, its 'Micro' designation highlights a fineness adapted to small calibre sutures. The instrument is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use and after each subsequent use. Due to its design and the materials used, the manufacturer Helmut Zepf specifies that there is no defined maximum limit for processing cycles, as long as the visual integrity of the instrument is preserved.

What are the contraindications for the use of this instrument?

The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity to metals. As the instrument is composed of medical stainless steel, contact with the patient may trigger an allergic reaction or intolerance in sensitive subjects. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore imperative to check the patient's allergic history before any use. Furthermore, the use of products showing visible damage, such as cracks or breaks, is formally prohibited.

What are the maintenance and reprocessing precautions?

The reprocessing of the Helmut Zepf micro needle holder must follow a rigorous protocol. All instruments must be cleaned, disinfected, and sterilized before the first use and after each use. It is crucial to inspect the instrument for any wear, cracks, or defects on the active parts before each intervention. The use of damaged or worn products is prohibited to guarantee patient safety. The manufacturer emphasizes that determining the number of achievable sterilization cycles depends on proper maintenance and the physical condition of the object, as no fixed limit is imposed by the materials. This device is exclusively reserved for qualified healthcare professionals.

Who is the manufacturer and what standards are respected?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This micro needle holder is classified as a Class I medical device according to current regulations. The manufacturer ensures the compliance of its products with safety and performance requirements. The manufacturing processes respect the rigorous standards of the medical industry for surgical instrumentation. Each instrument, identified by the reference 41.200.15TC, is subject to strict quality control to meet the needs of dental and implant surgery, thus ensuring traceability and reliability in line with the expectations of European practitioners.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.