4403a0ab-8a50-4d02-b81e-d47917a84474UpdatePublished92024-02-162016-09-07In Commercial Distribution05055270935403PackageGS10505527091401910In Commercial Distribution05055270914019PrimaryGS105055270956804PackageGS1050552709354036In Commercial DistributionRocketR57525-00-P1R57525-00-P1544313588ROCKET MEDICAL PLC1Rocket DIsposable Needle GuidetruefalsefalsetruefalsetruetruetruetruetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+4401914196988gudid@rocketmedical.comK03201500045018Needle 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.falseActiveDevice Size Text, specifyU/S transducer specificLumen/Inner DiameterStorage Environment TemperatureHandling Environment TemperatureHandling Environment HumidityStorage Environment HumidityStorage Environment Atmospheric PressureHandling Environment Atmospheric Pressuretruefalse