Sterile Kits Delynov per 1 Carton of 8 pieces - Mölnlycke - Delynov
The Kits Stériles Delynov par 1 Carton de 8 pièces - Mölnlycke is a medical device manufactured by Mölnlycke Health Care — Class I, CE marking CE2797.
- Compliance: Medical device Class I, CE marking CE2797.
- Manufacturer: Mölnlycke Health Care.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Mölnlycke sterile kit in boxes of 8 pieces?
The sterile kit offered by Mölnlycke is a ready-to-use set designed to meet asepsis requirements in surgery. Packaged in boxes of 8 units, this product facilitates stock management for facilities regularly performing surgical acts. Each kit is developed by Mölnlycke Health Care, a recognized manufacturer in the field of medical devices, guaranteeing a reliable solution for surgical field preparation. This device belongs to the category of protection and draping kits, essential for maintaining a sterile environment around the incision area. Its structure is designed for easy handling by the healthcare team, allowing for rapid setup of the dental or surgical sterile field before the start of the operative procedure.
What are the clinical indications for this kit?
This dental sterile field kit is primarily indicated for oral surgery, implantology, and periodontology interventions. Its use is recommended for any procedure requiring the maintenance of a rigorous sterility chain to prevent post-operative infections. In implantology, the use of an implantology surgery pack is a standard step to isolate the surgical site from non-sterile areas of the face or the chair. It is also suitable for complex extractions, bone grafts, or guided tissue regeneration surgeries. The device helps protect the patient and the healthcare staff by creating a physical barrier against microorganisms, thus respecting the strictest hospital and dental office hygiene protocols.
What are the technical characteristics of this device?
The Mölnlycke sterile kit is classified as a Class I medical device, meeting European regulatory requirements with CE2797 marking. This certification attests to the product's compliance with current safety and performance standards. Although detailed composition specifications are not specified, the manufacturer Mölnlycke Health Care ensures a design adapted to the constraints of operating rooms. The product is delivered in boxes of 8 pieces, with each kit individually wrapped to guarantee its sterility until the moment of opening. This format is particularly suitable for practitioners looking for a reliable sterile surgical field, certified both as a medical device (MD) and as personal protective equipment (PPE) for healthcare professionals.
What are the contraindications for the use of this kit?
According to the data provided by the manufacturer Mölnlycke Health Care, there are no specific contraindications listed for the use of this sterile kit. However, as with any medical device, it is imperative to refer to the instructions for use accompanying the products to check for any particular warnings. Use is exclusively reserved for healthcare professionals trained in aseptic techniques. The integrity of the individual packaging must be checked before use; if the pouch is punctured or damaged, sterility is no longer guaranteed and the kit must not be used. It should also be ensured that the patient does not have a known hypersensitivity to standard draping materials used in surgical settings.
What are the precautions for use and storage?
The use of this sterile surgical field requires strict adherence to aseptic opening protocols to avoid contaminating the kit contents. The product is for single use; any reuse is strictly prohibited to avoid risks of cross-contamination and the loss of protective barrier properties. After use, the kit must be disposed of in accordance with local procedures for the management of clinical waste with infectious risks (DASRI). For storage, it is recommended to keep the boxes of 8 pieces in a dry place, away from direct light and humidity, in order to preserve the integrity of the sterile packaging. Professionals must systematically consult the instructions for use to become aware of the manufacturer's specific warnings.
Who is the manufacturer and what standards are respected?
The official manufacturer of these kits is Mölnlycke Health Care AB, a global reference entity in the production of protective medical devices. This product benefits from the CE2797 marking, confirming its evaluation according to European safety standards. It is registered as a Class I medical device. In addition to its MD (Medical Device) certification, this kit is also certified as PPE (Personal Protective Equipment), highlighting its dual function of protection for both the patient and the practitioner. Manufacturing by Mölnlycke guarantees traceability and quality compliant with the requirements of modern operating rooms. For any additional information on technical standards or safety specifications, users are invited to consult the technical documentation provided by Mölnlycke.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
Specifications
| Manufacturer | Mölnlycke Health Care |
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