{"publicDeviceRecordKey":"a41a2ef9-cf69-4697-835d-8c91ee30a22a","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2021-02-05T00:00:00.000Z","devicePublishDate":"2015-09-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07613252192558","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TARGET","versionModelNumber":"M0035463080","catalogNumber":"546308","dunsNumber":"042405446","companyName":"Stryker Corporation","deviceCount":1,"deviceDescription":"360 Standard Detachable Coil","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(855)916-3876","phoneExtension":null,"email":"NVCustomerService@stryker.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60940","gmdnPTName":"Neurovascular embolization coil","gmdnPTDefinition":"A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.","implantable":true,"gmdnCodeStatus":"Active"},{"gmdnCode":"60941","gmdnPTName":"Non-neurovascular embolization coil","gmdnPTDefinition":"A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HCG","productCodeName":"DEVICE, NEUROVASCULAR EMBOLIZATION"},{"productCode":"KRD","productCodeName":"Device, Vascular, for Promoting Embolization"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Coil Length: 8.0 Centimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Secondary Coil Diameter: 3.0 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in cool, dry, dark place."}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}