VITROPRO ST ENDO IVF NEEDLE - Type: GD GE E8C
Product information
- Quantity Unit Packet
- Contains 24 Single
- Product Code None
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Description
The VitroPRO ST ENDO IVF Needle is a specialized medical device designed to enhance precision and safety during IVF oocyte retrieval and other ultrasound-guided procedures. This single-use, disposable endocavity needle guide is crafted to provide a clear and accurate needle path, significantly reducing the risk of microbial contamination and ensuring protection against endotoxins.
Key Features
- Compatibility: Designed for use with a wide range of diagnostic ultrasound endocavity transducers from leading manufacturers such as Canon, Siemens, GE Healthcare, Philips, and more. Available in various sizes to accommodate different clinical needs.
- Material Composition: Constructed with a stainless steel cannula and ABS thermoplastic, ensuring durability and reliability.
- Sterility and Safety: Each device is sterile, MEA and LAL tested, with endotoxin levels maintained at 20 EU or less per device. It meets ISO 10993-1 biocompatibility standards, demonstrating non-toxicity, non-sensitization, non-irritation, and non-pyrogenicity.
- Shelf Life: Sterilized using ethylene oxide with a shelf life of 3 years.
Intended Use
This device is intended for healthcare professionals in IVF clinics, suitable for both transvaginal and transrectal procedures. It is prescription-only, ensuring it is used by qualified personnel.
Regulatory Compliance
Classified as a Class II medical device, it adheres to regulatory standards 21 CFR 892.1570 and 21 CFR 884.6100, with product code ITX. The device undergoes rigorous non-clinical testing, including biocompatibility, retention, movement, and needle path verification, ensuring performance equivalent to other legally marketed guides.
Packaging
Packaged in quantities of 24, the VitroPRO ST ENDO IVF Needle does not include accessories, requiring users to provide compatible covers and guides cleared for IVF use.
This product exemplifies VitroPRO's commitment to quality and innovation, providing essential tools for healthcare professionals engaged in critical reproductive and diagnostic procedures.