{"publicDeviceRecordKey":"660e8af8-cb2e-4016-bb58-310f59aecce3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-08-21T00:00:00.000Z","devicePublishDate":"2016-08-01T00:00:00.000Z","deviceCommDistributionEndDate":"2017-11-30T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00650551027331","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MACROVAC®","versionModelNumber":"3201-07M-09-PF","catalogNumber":"3201-07M-09-PF","dunsNumber":"039576871","companyName":"PMT CORPORATION","deviceCount":1,"deviceDescription":"MEDIUM TIP, POLISH FINISH\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":"800-626-5463","phoneExtension":null,"email":"intl@pmtcorp.com"},{"phone":"800-626-5463","phoneExtension":null,"email":"info@pmtcorp.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"57822","gmdnPTName":"Surgical irrigation/aspiration handpiece, reusable","gmdnPTDefinition":"A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GZX","productCodeName":"Instrument, Microsurgical"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"7"},"sizeText":null,"sizeString":"Catheter Gauge: 7 French"},{"sizeType":"Length","size":{"unit":"Inch","value":"9"},"sizeText":null,"sizeString":"Length: 9 Inch"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"78"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"58"},"storageHandlingSpecialConditionText":null}]},"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":[]}}