{"publicDeviceRecordKey":"663a3d88-f03e-422b-8dce-ec2b0a9354d1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-12-25T00:00:00.000Z","devicePublishDate":"2023-11-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M368744COM1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"INTENSA","versionModelNumber":"744-COM","catalogNumber":null,"dunsNumber":"132016168","companyName":"GF HEALTH PRODUCTS, INC.","deviceCount":1,"deviceDescription":"HYDRAULIC SURGICAL STOOL","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"7703684700","phoneExtension":null,"email":"cs@grahamfield.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32307","gmdnPTName":"Operating room stool, manually-adjusted","gmdnPTDefinition":"A manually-operated seat intended to be occupied by a surgeon or operating room (OR) staff [e.g., surgical nurses, surgical assistants, anaesthetists] during surgical procedures as an alternative to standing. It may provide the occupier with support for the back or arms. It is typically designed with at least one manually-operated ergonomic adjustment (e.g., height and position adjustments), which is typically adjusted by a hand or foot lever, and may features wheels (castors) and breaks.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FZM","productCodeName":"Stool, Operating-Room"}]},"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":[]}}