{"publicDeviceRecordKey":"29014d03-1271-46b8-9470-20c875bf2bf1","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-01-24T00:00:00.000Z","devicePublishDate":"2025-01-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840306831270","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Marina Medical","versionModelNumber":"380-336","catalogNumber":"380-336","dunsNumber":"011442279","companyName":"MARINA MEDICAL INSTRUMENTS, INC.","deviceCount":1,"deviceDescription":"Lateral Vaginal Retractor, Laser Finished, 9 x 2cm (3.5 x .75\") Blades","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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(954)924-4418","phoneExtension":"115","email":"enrico@marinamedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"11268","gmdnPTName":"Vascular dilator, reusable","gmdnPTDefinition":"A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GAD","productCodeName":"RETRACTOR"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"9"},"sizeText":null,"sizeString":"Length: 9 Centimeter"}]},"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":[]}}