{"publicDeviceRecordKey":"a1420245-1774-45da-adc7-f222b68c903d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2022-11-02T00:00:00.000Z","devicePublishDate":"2016-08-09T00:00:00.000Z","deviceCommDistributionEndDate":"2021-03-11T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046964341663","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Mini Ghost™","versionModelNumber":"612563","catalogNumber":"612563","dunsNumber":"784259751","companyName":"B BRAUN INTERVENTIONAL SYSTEMS, INC","deviceCount":1,"deviceDescription":"MG121 MINI GHOST BALLOON 3. 5X2 X 120","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(877)836-2228","phoneExtension":null,"email":"GUDID.BBMUS_Service@bbraun.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K051343","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17184","gmdnPTName":"Peripheral angioplasty balloon catheter, basic","gmdnPTDefinition":"A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQY","productCodeName":"CATHETER, PERCUTANEOUS"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"ROOM TEMP AWAY FROM SUNLIGHT"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}