91a97669-5f92-43a2-9c19-990d48536208NewPublished12026-05-192026-05-11In Commercial DistributionB201CGSG141PackageHIBCCB201CGSG1401In Commercial DistributionUnit BoxB201CGSG140PrimaryHIBCCB201CGSG142PackageHIBCCB201CGSG1414In Commercial DistributionPacker Shelf BoxB201CGSG143PackageHIBCCB201CGSG1421In Commercial DistributionMailer BoxB201CGSG144PackageHIBCCB201CGSG14216In Commercial DistributionShipper BoxClear Guide SteriGRIDCGSG14CG-SG14965399905CLEAR GUIDE MEDICAL, INC.1The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT) falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseMR Safetruefalse+1 (443) 267-7661support@clearguidemedical.comK23403000045018Needle 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.falseActiveIWJSystem, Applicator, Radionuclide, ManualITXTransducer, Ultrasonic, DiagnosticOIJBiopsy Needle Guide KitNeedle Gaugetruefalse