{"publicDeviceRecordKey":"2adf6966-d944-4d82-b36d-3e7aebe90d77","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2026-01-09T00:00:00.000Z","devicePublishDate":"2016-09-21T00:00:00.000Z","deviceCommDistributionEndDate":"2024-08-29T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M84965250","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Freeman Pancreatic Flexi-Stent Kit","versionModelNumber":"6525","catalogNumber":"6525","dunsNumber":"076769355","companyName":"HOBBS MEDICAL, INC.","deviceCount":1,"deviceDescription":"Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single-use device.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"8606845875","phoneExtension":null,"email":"customerservice@hobbsmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K834351","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"42701","gmdnPTName":"Polymeric pancreatic stent, non-bioabsorbable","gmdnPTDefinition":"A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FGE","productCodeName":"Catheter, Biliary, Diagnostic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}