{"publicDeviceRecordKey":"e03a734f-92f6-414a-adb8-4ffd4a6a4336","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-03-13T00:00:00.000Z","devicePublishDate":"2025-03-05T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G4533324129VT0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PEAK MEDICAL","versionModelNumber":"33241-29VT","catalogNumber":null,"dunsNumber":"078393632","companyName":"Peak Medical Distribution Inc.","deviceCount":1,"deviceDescription":"AV Fistula Tunneler 4mm vein tip w/luer adaptor","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35377","gmdnPTName":"Vein stripper, reusable","gmdnPTDefinition":"A hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DWS","productCodeName":"Instruments, Surgical, Cardiovascular"}]},"deviceSizes":{"deviceSize":[]},"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":[]}}