{"publicDeviceRecordKey":"3bfa68c4-41f6-493c-8675-468bef6680b4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-02-19T00:00:00.000Z","devicePublishDate":"2015-10-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"ESAM23051161","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"ESAM23051160","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"STOMA® titanium bone screw","versionModelNumber":"23051.16","catalogNumber":"23051.16","dunsNumber":"318268125","companyName":"Storz am Mark GmbH","deviceCount":3,"deviceDescription":"STOMA® titanium bone screws Ø1,6 X 16mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. STOMA® titanium bone screws are delivered in non-sterile conditions.","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"9999999999","phoneExtension":null,"email":"sam@stoma.de"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K051871","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"56642","gmdnPTName":"Orthopaedic bone screw, non-bioabsorbable, non-sterile","gmdnPTDefinition":"A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A \"lag screw\" can be any of these used to obtain compression. This device must be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"DZL","productCodeName":"Screw, Fixation, Intraosseous"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"1.6"},"sizeText":null,"sizeString":"Outer Diameter: 1.6 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"16"},"sizeText":null,"sizeString":"Length: 16 Millimeter"}]},"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}