{"publicDeviceRecordKey":"8b851714-d32c-4370-8c0f-3ee7f0e65210","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2025-10-29T00:00:00.000Z","devicePublishDate":"2017-12-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00887482105191","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Symmetry Ultra™ Reveal","versionModelNumber":"59-1053","catalogNumber":"59-1053","dunsNumber":"027680821","companyName":"ASPEN SURGICAL PRODUCTS, INC.","deviceCount":1,"deviceDescription":"Ultra® Instruments Blade; Reveal Lumbar; Angled Out 15°; 45 mm x 80 mm; Titanium; w/Teeth","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1 888-364-7004","phoneExtension":null,"email":"customerservice@symmetrysurgical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46774","gmdnPTName":"Surgical retractor/retraction system blade, reusable","gmdnPTDefinition":"A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DWH","productCodeName":"Blade, Saw, Surgical, Cardiovascular"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Width","size":{"unit":"Millimeter","value":"45"},"sizeText":null,"sizeString":"Width: 45 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"80"},"sizeText":null,"sizeString":"Length: 80 Millimeter"},{"sizeType":"Angle","size":{"unit":"degree","value":"15"},"sizeText":null,"sizeString":"Angle: 15 degree"}]},"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":[]}}