{"publicDeviceRecordKey":"a2ce295b-6cc7-4426-8bff-8bec3bc94ffd","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2015-10-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00836462003019","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SilverSpeed","versionModelNumber":"103-0601-200","catalogNumber":"103-0601-200","dunsNumber":"826110710","companyName":"Micro Therapeutics, Inc.","deviceCount":1,"deviceDescription":"10 Hydrophilic Guidewire","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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(508)261-8000","phoneExtension":null,"email":"covidien.udi@covidien.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K982543","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35094","gmdnPTName":"Cardiac/peripheral vascular guidewire, single-use","gmdnPTDefinition":"A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQX","productCodeName":"WIRE, GUIDE, CATHETER"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"200"},"sizeText":null,"sizeString":"Length: 200 Centimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Guidewire,.010,Inch;"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"90"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"50"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}