{"publicDeviceRecordKey":"fce4c5b9-ec48-46ba-9b1c-91417643b9cf","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-11-18T00:00:00.000Z","devicePublishDate":"2019-11-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00846159020175","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SCANLAN®  Miscellaneous Instruments","versionModelNumber":"4004-043","catalogNumber":"4004-043","dunsNumber":"023055619","companyName":"SCANLAN INTERNATIONAL INC","deviceCount":1,"deviceDescription":"DEBAKEY FORCEPS BAYONET SHAPED SHANKS 1.5MM TIPS 9 1/2\" 24CM","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"651-298-0997","phoneExtension":null,"email":"vanderpoelw@scanlangroup.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62466","gmdnPTName":"Surgical soft-tissue manipulation forceps, tweezers-like, reusable","gmdnPTDefinition":"A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEN","productCodeName":"Forceps, General \u0026 Plastic Surgery"}]},"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":[]}}