{"publicDeviceRecordKey":"5d76a6ba-7ffd-4811-ae7c-e7436c0cbfd8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-03-25T00:00:00.000Z","devicePublishDate":"2016-02-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"28717648080092","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08717648080098","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"08717648080098","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"HI-TORQUE FLOPPY","versionModelNumber":"22339M","catalogNumber":"22339M","dunsNumber":"964569052","companyName":"ABBOTT VASCULAR INC.","deviceCount":1,"deviceDescription":"HI-TORQUE FLOPPY II Guide Wire .014 Straight Tip 2.0 cm x 190 cm","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(800)227-9902","phoneExtension":null,"email":"AV.CUSTOMERCARE@AV.ABBOTT.COM"}]},"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":"Guidewire Diameter","size":{"unit":"Inch","value":"0.0140"},"sizeText":null,"sizeString":"Guidewire Diameter: 0.0140 Inch"},{"sizeType":"Guidewire Length","size":{"unit":"Centimeter","value":"190.0000"},"sizeText":null,"sizeString":"Guidewire Length: 190.0000 Centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in a dry, dark, cool place"}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}