Sterile Scalpel Blade MJK Number 1 (BW001) - Delynov
The Lame de bistouri stérile MJK numéro 1 is a medical device manufactured by MJK Instruments AG — Class IIa, CE marking CE0246.
- Compliance: Medical device Class IIa, CE marking CE0246.
- Manufacturer: MJK Instruments AG.
- Reference: BW001.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the MJK number 1 scalpel blade?
The MJK sterile scalpel blade number 1, referenced under code BW001, is a single-use cutting instrument intended for surgical interventions. This medical device from the MJK brand is designed to offer optimal cutting performance during clinical procedures. As a dental surgery consumable, this blade is sterile-packaged to ensure the microbiological safety of both the patient and the practitioner. It constitutes a fundamental element of the technical platform for soft tissue management in dental offices or hospital environments.
What are the clinical indications?
According to the manufacturer's data, this scalpel blade is specifically indicated for surgery and soft tissue incision. In daily practice, dental surgeons and implantologists use this type of blade to create flaps, release incisions, or tissue samples. The MJK scalpel blade allows for precise and controlled penetration into the mucous membranes, thus facilitating visual and instrumental access to underlying structures during periodontal or pre-implant surgeries.
What are the technical characteristics?
The MJK scalpel blade number 1 (reference BW001) is a Class IIa medical device, meeting current safety and performance requirements. It carries the CE0246 marking, certifying its compliance with European standards. The official manufacturer is MJK Instruments AG, although production is carried out by Susruta Instruments Pvt Ltd. This device is characterized by extreme sharpness, requiring rigorous handling by qualified healthcare professionals to avoid any risk of accidental injury during mounting or use on the scalpel handle.
What are the contraindications for use?
The provided regulatory text does not mention specific medical contraindications related to the composition or use of the MJK number 1 scalpel blade. However, the use of this device is strictly reserved for healthcare professionals trained in surgical techniques. It is imperative not to use the product if the sterile packaging is damaged, in order to prevent any risk of infectious complications. As with any sharp instrument, particular attention must be paid when used in patients with uncontrolled coagulation disorders.
What are the precautions for use and safety?
The MJK scalpel blade is an extremely sharp device that requires constant vigilance. It is exclusively reserved for use by healthcare professionals. Before any use, it is essential to carefully read the instructions for use provided by the manufacturer. Being a single-use device, any attempt at resterilization or reuse is prohibited to avoid risks of cross-contamination and the loss of cutting properties. After use, the blade must be disposed of in a sharps container compliant with protocols for the disposal of clinical waste (DASRI).
Who is the manufacturer and what standards are respected?
The number 1 scalpel blade (BW001) is marketed under the MJK brand. The official manufacturer is MJK Instruments AG, with manufacturing performed by Susruta Instruments Pvt Ltd located in Ahmedabad, India. This medical device is certified Class IIa and bears the CE0246 marking. These certifications guarantee that the product respects the strict manufacturing processes and quality controls imposed by European medical device regulations. Traceability and sterility are central elements of the compliance of this dental surgery consumable distributed by Delynov.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | MJK Professional Dental Instruments |
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