{"publicDeviceRecordKey":"32967f12-87a8-4ea8-9f46-e13c1523650a","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-09-30T00:00:00.000Z","devicePublishDate":"2024-09-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04049197457828","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"RZ Medizintechnik GmbH","versionModelNumber":"290-471-215","catalogNumber":"290-471-215","dunsNumber":"312953227","companyName":"RZ-Medizintechnik GmbH","deviceCount":1,"deviceDescription":"Cooley Mulit-Purpose Clamp              \ncurved, 215mm, 8 1/4''                  \n","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+49746294700","phoneExtension":null,"email":"info@rz-medizintechnik.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62468","gmdnPTName":"Surgical soft-tissue manipulation forceps, scissors-like, reusable","gmdnPTDefinition":"A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GDJ","productCodeName":"CLAMP, SURGICAL, 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":[]}}