{"publicDeviceRecordKey":"d614eeb5-8bb1-42af-8378-a2aff28d7119","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2026-03-27T00:00:00.000Z","devicePublishDate":"2025-08-14T00:00:00.000Z","deviceCommDistributionEndDate":"2025-10-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00810147255672","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Mastel Surgical","versionModelNumber":"U-OE-ST35-8","catalogNumber":"80.U-OE-ST35-8","dunsNumber":"197053028","companyName":"INTERNATIONAL SURGICAL PRODUCTS INC","deviceCount":1,"deviceDescription":"8\" OPEN END U STRINGER 3.5\" WIDE\n","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":"64168","gmdnPTName":"Sterilization stringer","gmdnPTDefinition":"A device designed to hang hinged, ring-handled surgical instruments (e.g. forceps, scissors) in an open position during sterilization. Often referred to as an instrument stringer, it is typically in the form of a U-/D-shaped locking bar. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MDM","productCodeName":"Instrument, Manual, Surgical, General Use"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"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":[]}}