{"publicDeviceRecordKey":"55dc560a-90bf-4d25-a1fa-cc510480e8cf","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-06-19T00:00:00.000Z","devicePublishDate":"2015-10-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"09321502018951","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Baha","versionModelNumber":"92132","catalogNumber":"92132","dunsNumber":"559784736","companyName":"Cochlear Bone Anchored Solutions AB","deviceCount":1,"deviceDescription":"BA210 abutment 5.5mm for flange fixture","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)523-5798","phoneExtension":null,"email":"customer@cochlear.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K955713","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46638","gmdnPTName":"Craniofacial bone screw, non-bioabsorbable","gmdnPTDefinition":"A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LXB","productCodeName":"Hearing aid, bone conduction"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Abutment 5.5 mm"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"5.5"},"sizeText":null,"sizeString":"Length: 5.5 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Radiation Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}