{"publicDeviceRecordKey":"593ec12b-3dae-4d9f-8878-71a369ed35ed","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-09-18T00:00:00.000Z","devicePublishDate":"2022-08-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840285318878","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Walcott Rx Products","versionModelNumber":"Rx424","catalogNumber":null,"dunsNumber":"837689694","companyName":"Walcott Rx Product Inc","deviceCount":1,"deviceDescription":"Forcep","DMExempt":true,"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(800)837-9875","phoneExtension":null,"email":"sales@walcottrx.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63411","gmdnPTName":"Ophthalmic surgical device handling forceps, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. It has a tweezers-like design (may be a micro/fine instrument) with two blades joined at the proximal (non-working) end which have variously designed tips at the working end, typically with a slot/groove to accept the ophthalmic device; it is made of metal and is available in various sizes. This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HNR","productCodeName":"Forceps, ophthalmic"}]},"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":[]}}