2b529a36-6aca-4789-9f7c-d80644021f89UpdatePublished52024-02-162021-07-07In Commercial Distribution00841912106936PrimaryGS1Multi Angle Biopsy Starter Kit7196965417181PROTEK MEDICAL PRODUCTS, INC.1Multi Angle Biopsy Starter Kit for Samsung Medison CA1-7S Ultrasound TransducersfalsefalsefalsetruefalsefalsetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse58248Ultrasound imaging system tracking positioner, reusableA metal or plastic bracket intended to be applied to a hand-held ultrasound (US) transducer for the repeatable positioning (detach from/reattach to same place) of an electromagnetic (EM) sensor and/or needle guide on the transducer. It may be used in conjunction with an EM device tracking system and is intended for applications involving needle guidance and tracking such as ablation, core tissue biopsy, fluid aspiration, therapeutic delivery and vascular access. Disposable needle guides and imaging-supportive devices (e.g., US transducer cover/gel) may be included with the positioner; the transducer and sensor are not included. This is a reusable device.falseActive45018Needle 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.falseActiveSpecial Storage Condition, SpecifyKeep away from sunlightfalsetrueHigh-level Disinfectant