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The purpose of this Guideline is to provide clarity and guidance regarding the use of a digital pathology system which utilizes artificial intelligence (AI)-based image analysis algorithms. It describes the intended use of the system and covers relevant considerations related to its functionality, setup, and use in a pathology laboratory environment. This includes the following: * Clear indications for use, including the patient population, sample type, purpose of the analysis, and interpretation of the results. * Description of the AI algorithms used, including their validation and performance characteristics. * Guidelines for system setup and configuration, including hardware and software requirements, calibration procedures, and quality control measures. * Recommendations for training and competency assessment of users. * Instructions for data management and archiving. * Considerations for potential limitations and risks associated with the use of the system. * Reporting of results, including integration with laboratory information systems. * Post-market surveillance and system updates. * Adherence to relevant regulatory requirements and standards. By following this Guideline, pathology laboratories can ensure the safe and effective use of AI-based image analysis in digital pathology, contributing to improved diagnostic accuracy and patient care.

A compact USB-C hub designed to expand connectivity options, featuring multiple ports including USB-A, HDMI, SD card reader, and a passthrough charging port, ideal for laptops with limited ports.

The K-Pack Enhance Needle a sterile, hypodermic needle, for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The K-Pack Enhance Needle is for general application - for injection of fluids or withdrawal of fluids.

The K-Pack Enhance Needle is a sterile hypodermic needle for single use consisting of a stainless steel cannula with nominal outside diameter of 0.33 mm or 0.40 mm and a length of 12 mm. The cannula is sharpened at one end and has 45° cut at the other end, which is joined to a female luer connector (hub) made of polycarbonate (PC) designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Enhance Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label. The case serves as needle protector. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide.

The Terumo Injection Filter Needle is intended to inject fluids. The Terumo Injection Filter Needle is indication - for treatment - injection of fluids into parts of the body below the surface of the skin and into the vitreous.

The Terumo Injection Filter Needle is a sterile injection needle for single use consisting of a stainless steel cannula with nominal outside diameter of 0.3 mm and length of 12 mm that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polymethyl methacrylate designed to be connected with a male luer connector (nozzle) of a syringe. The integrated 5u filter in the hub is intended to prevent particles from being injected. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide. Its operation is manual. The Terumo Injection Filter Needle protector and is individually packed in a soft blister made of paper and film and sterilized by ethylene oxide.

The TERUMO SurGuard®3 SAFETY HYPODERMIC NEEDLE is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The SurGuard®3 Safety Hypodermic Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The SurGuard®3 Safety Hypodernic Needle is compatible for use with standard luer slip and luer lock syringes. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheath-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the risk of accidental needlestick. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation. The SurGuard®3 Safety Hypodermic Needle will be individually packaged and sterilized by ethylene oxide.

The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall being Hypodermic Single Lumen Needles are sterile medical devices for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

The subject K-Pack II Needles are hypodermic single lumen needles, for single use consisting of stainless steel that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a hypodermic syringe. The needle is packed in a hard pack (cap-case) made of polypropylene. The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall will be an extension of the existing K-Pack II Needles product family.

The "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is a hypodermic syringe with fixed needle intended for manual aspiration of GONAL-f Multi-Dose and for the solution into parts of the body below the surface of the skin. The syringes designed for manual use are intended for use soon after filling, as they are not suitable for containing GONAL-f Multi-Dose over extended periods of time.

The "Syringe with fixed needle – For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is comprised of a standard piston syringe with a permanently attached (fixed) hypodermic single lumen needle designed for the manual aspiration and injection of GONAL-f Multi-Dose. The needle is covered by a protective cap. The graduated scale is specifically designed for GONAL-f Multi-Dose. This syringe is a 1 ml syringe with 27G x 12" fixed needle. This is a single use syringe.

The 29G x 5/16" Thin Wall K-Pack II Needles being Hypodermic Single Lumen Needles are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.

The 21G x 2" K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.

The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system, for single-dose or short-term intravenous administration of fluids using a syringe or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

The 23G and the 25G Terumo Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield), are sterile, single use devices consisting of a needle attached to a winged hub, microbore tubing, adapter with integrated 20 um filter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto the needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The device possesses a 350 mm length microbore tubing.