MICRO NEEDLE HOLDER STRAIGHT - Helmut Zepf (41.010.17TC-M)
The MICRO PORTE AIGUILLE DROIT - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 41.010.17TC-M.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf straight micro needle holder?
The Helmut Zepf straight micro needle holder, referenced under code 41.010.17TC-M, is a manual surgical instrument intended for the firm holding of suture needles. Manufactured by Helmut Zepf Medizintechnik GmbH, this device belongs to the category of Class I consumables and instruments. Its structure is specifically adapted to micro-surgery interventions where precision of movement is paramount. Designed in medical stainless steel, it offers the necessary resistance for repeated manipulations in a clinical environment. This instrument is delivered non-sterile and must undergo a complete cycle of cleaning, disinfection, and sterilization before its first use and after each surgical act to guarantee the safety of the patient and the practitioner.
What are the clinical indications for this instrument?
According to data from the manufacturer Helmut Zepf, this straight micro needle holder is indicated for holding and manipulating needles during surgical suturing. In oral and implant surgery, it allows the practitioner to perform precise sutures for the approximation of wound edges or the fixation of membranes. Its use is reserved exclusively for qualified healthcare professionals. It is involved in all phases of tissue reconstruction requiring fine management of soft tissues. The instrument must be inspected before each use to detect any visible damage such as cracks or breaks that could compromise its clinical efficacy.
What are the technical characteristics of reference 41.010.17TC-M?
The Helmut Zepf straight micro needle holder (41.010.17TC-M) is distinguished by its medical stainless steel design, a standard material for Class I surgical instrumentation. Although exact dimensions are not specified, its 'micro' designation indicates an architecture adapted to small calibre needles used in fine surgery. The working part is designed to provide a stable grip without damaging the needle body. Like any dynamic instrument in this category, it does not have a defined maximum limit of processing cycles, but its longevity depends on strict compliance with cleaning protocols and the absence of visible wear on the jaws or the locking mechanism.
What are the contraindications for the use of this needle holder?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns metal intolerance. A hypersensitivity reaction may occur in the patient upon contact with the medical stainless steel instrument. If such a reaction manifests during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. It is therefore recommended to evaluate the patient's allergic history before any intervention. Furthermore, the use of the instrument is strictly prohibited if it shows visible defects, damaged cutting edges, or signs of corrosion, in order to avoid any risk of intraoperative complication.
What are the maintenance and reprocessing precautions?
The straight micro needle holder is delivered non-sterile. A strict reprocessing protocol is mandatory before the first use and after each subsequent use. This includes complete cleaning, disinfection, and sterilization. The manufacturer emphasizes that it is crucial to check compatibility with other products used simultaneously. Due to its design and the materials used, there is no predefined maximum number of sterilization cycles. However, the practitioner must perform a systematic visual check to identify any wear, cracks, or malfunction. Any damaged or worn instrument must never be reused in surgery.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is a Class I instrument compliant with current regulations for medical devices (MDC0483). The manufacturer ensures the traceability and quality of the medical stainless steel used for the design of the straight micro needle holder. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to guarantee the conformity of the device during its clinical application. The instrument is exclusively intended for professional use by practitioners trained in surgical suture techniques.
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| Manufacturer | Helmut Zepf |
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