85be8e01-bf80-4a76-9530-5e1faef820c5UpdatePublished42024-02-162021-05-17In Commercial Distribution10841912106902PackageGS10084191210690524In Commercial Distribution00841912106905PrimaryGS1Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit53645364965417181PROTEK MEDICAL PRODUCTS, INC.1Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C41 Ultrasound TransducersfalsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK970893000K97395800045018Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.falseActive44713Body-surface ultrasound imaging transducer coverA device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.falseActiveITXTransducer, Ultrasonic, DiagnosticKKXDrape, Surgicaltruefalse