{"publicDeviceRecordKey":"961de1c8-f1a3-4e09-aa62-978b5444feff","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2021-02-05T00:00:00.000Z","devicePublishDate":"2015-10-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04946329059731","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SUGITA TITANIUM ANEURYSM CLIP","versionModelNumber":"07-934-12","catalogNumber":"07-934-12","dunsNumber":"690677802","companyName":"MIZUHO CORPORATION","deviceCount":1,"deviceDescription":"TYPE: STANDARD, PERMANENT, No.12\nRANGE: 140-175gf(1.37-1.72N)\nMATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2\nBLADE: BENT\nMAXIMUM OPENING: 8.0mm\nGRIP SURFACE: SERRATED","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"9999999999","phoneExtension":null,"email":"regulatory@mizuho.co.jp"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34958","gmdnPTName":"Aneurysm clip","gmdnPTDefinition":"A metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically an alpha-shaped coil spring, with blades that open like jaws, that comes with a dedicated applier for application to the aneurysm. The device is available in a variety of sizes and its blades may be straight or curved. It is typically used to treat intracranial aneurysms; it may also be used to prevent bleeding from small blood vessels.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HCH","productCodeName":"Clip, Aneurysm"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"12"},"sizeText":null,"sizeString":"Length: 12 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}