{"publicDeviceRecordKey":"91a97669-5f92-43a2-9c19-990d48536208","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-05-19T00:00:00.000Z","devicePublishDate":"2026-05-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B201CGSG141","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B201CGSG140","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Unit Box"},{"deviceId":"B201CGSG140","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"B201CGSG142","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B201CGSG141","pkgQuantity":4,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Packer Shelf Box"},{"deviceId":"B201CGSG143","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B201CGSG142","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Mailer Box"},{"deviceId":"B201CGSG144","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B201CGSG142","pkgQuantity":16,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Shipper Box"}]},"brandName":"Clear Guide SteriGRID","versionModelNumber":"CGSG14","catalogNumber":"CG-SG14","dunsNumber":"965399905","companyName":"CLEAR GUIDE MEDICAL, INC.","deviceCount":1,"deviceDescription":"The 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) ","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1 (443) 267-7661","phoneExtension":null,"email":"support@clearguidemedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K234030","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45018","gmdnPTName":"Needle guide, single-use","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IWJ","productCodeName":"System, Applicator, Radionuclide, Manual"},{"productCode":"ITX","productCodeName":"Transducer, Ultrasonic, Diagnostic"},{"productCode":"OIJ","productCodeName":"Biopsy Needle Guide Kit"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"14"},"sizeText":null,"sizeString":"Needle Gauge: 14 Gauge"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}