Micro dull scalpel sterile spoon MJK number 3 (SB003) - Delynov
The Micro lame bistouri cuillère stérile MJK numéro 3 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: SB003.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the MJK number 3 sterile spoon micro scalpel blade?
The MJK number 3 micro scalpel blade, referenced under code SB003, is a high-precision cutting instrument intended for micro-surgery. This medical device, manufactured by MJK Instruments AG, is distinguished by its "spoon" shape, specifically developed for interventions requiring great finesse. Delivered sterile, this blade is an essential consumable (CONSO) for practitioners performing complex surgical acts where the workspace is restricted. It is designed to be mounted on a suitable micro-scalpel handle to guarantee safe handling and optimal cutting efficiency during the operative act.
What are the clinical indications for this micro-blade?
The intended use of the MJK SB003 micro scalpel blade is strictly defined by the manufacturer for surgery and, more precisely, for soft tissue incision. In clinical practice, it is particularly requested during periodontal or implant surgeries requiring relief incisions or very localized connective tissue grafts. Its spoon blade design allows for approaching tissues with a specific angle of attack, facilitating work in interproximal areas or during the creation of thin flaps. It meets the requirements of healthcare professionals seeking a sharp instrument for technical maneuvers on mucous membranes.
What are the technical characteristics of this device?
This MJK micro-blade presents rigorous technical characteristics to meet hospital and clinical standards. It belongs to regulatory Class IIa and benefits from the CE0246 marking, attesting to its compliance with current European requirements. The official manufacturer, MJK Instruments AG, ensures guaranteed sterility for each unit, thus minimizing the risks of cross-contamination. Its technical reference SB003 corresponds to configuration number 3 of the range. Although the exact material composition is not specified, the manufacturer emphasizes that the device is extremely sharp, requiring expert handling by a qualified healthcare professional.
What are the contraindications for the use of the SB003 micro-blade?
According to data provided by the manufacturer Susruta Instruments Pvt Ltd, there are no specific medical contraindications listed outside of the intended use for soft tissue incision in surgery. However, the use of this micro scalpel blade is strictly reserved for healthcare professionals trained in surgical techniques. Misuse or application on hard tissues (bone, enamel) could damage the blade's edge or compromise patient safety. It is imperative to read the instructions carefully before any use to ensure the suitability of the device with the planned clinical procedure and the patient's physiological state.
What are the precautions for use for this sterile device?
The MJK micro scalpel blade is an extremely sharp device that requires increased vigilance during unpacking and mounting on the handle. Being delivered sterile, it must be used immediately after opening the pouch to maintain the asepsis of the operative field. This is a single-use device; any reuse is prohibited to avoid infection risks and loss of cutting power. After the procedure, the blade must be disposed of in a sharps container compliant with protocols for the disposal of infectious clinical waste. Compliance with these precautions guarantees the safety of the practitioner and their assistant.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is MJK Instruments AG, with manufacturing handled by Susruta Instruments Pvt Ltd, located in Ahmedabad, India. This medical product is certified Class IIa and bears the CE0246 marking, guaranteeing compliance with European safety and performance standards. Traceability and manufacturing quality are at the heart of the processes of MJK, a recognized brand in the surgical instrumentation sector. As a professional medical device, it meets the requirements of the Medical Device Regulation (MDR), thus ensuring dental surgeons and implantologists a reliable and compliant tool for their daily interventions in private practice or hospital settings.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | MJK Professional Dental Instruments |
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