{"publicDeviceRecordKey":"e29bc4a2-3644-4a09-8086-b48f33e07a70","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2026-04-07T00:00:00.000Z","devicePublishDate":"2016-09-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00811608018317","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"HRX ACS (VHRXVITACS)","versionModelNumber":"VHRXVITACS","catalogNumber":null,"dunsNumber":"071125835","companyName":"VOLK OPTICAL INC.","deviceCount":1,"deviceDescription":null,"DMExempt":true,"premarketExempt":false,"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":false,"otc":false,"contacts":{"customerContact":[{"phone":"440-942-6161","phoneExtension":null,"email":"apoorva.agarwal@volk.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K023221","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58037","gmdnPTName":"Vitrectomy contact lens, reusable","gmdnPTDefinition":"A non-sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), It is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a reusable device that must be sterilized before application.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HJK","productCodeName":"Lens, Contact, Polymethylmethacrylate, Diagnostic"}]},"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}