{"publicDeviceRecordKey":"467d107c-95bf-4b60-9df1-7ae365f25cf9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2020-01-20T00:00:00.000Z","devicePublishDate":"2018-12-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00814008026036","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"FOCUS","versionModelNumber":"PD-1000T-101","catalogNumber":null,"dunsNumber":"047486041","companyName":"NVISION BIOMEDICAL TECHNOLOGIES, INC.","deviceCount":1,"deviceDescription":"Open Probe, Duckbill, Small.  The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.","DMExempt":true,"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":"210-545-3713","phoneExtension":null,"email":"diana@nvisionbiomed.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44759","gmdnPTName":"General internal orthopaedic fixation system implantation kit","gmdnPTDefinition":"A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MDM","productCodeName":"Instrument, Manual, Surgical, General Use"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time."}]},"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":[]}}