{"publicDeviceRecordKey":"794eb9c8-728f-425b-9bca-b8932c85f7f4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2026-01-19T00:00:00.000Z","devicePublishDate":"2019-03-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B6142101011","deviceIdType":"Previous","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"B614AB20001","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AquaBeam Robotic System","versionModelNumber":"AB2000","catalogNumber":"AB2000","dunsNumber":"016646472","companyName":"PROCEPT BioRobotics Corporation","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(650)232-7222","phoneExtension":null,"email":"customerservice@procept-biorobotics.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"DEN170024","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45396","gmdnPTName":"Water jet knife system","gmdnPTDefinition":"An assembly of devices designed to surgically cut/dissect soft body tissues using a stream of high pressure water, leaving hard/elastic structures (e.g., bone, ligaments) intact. It includes a mains electricity (AC-powered) generator to create the hydraulic pressure, tubing, and a handpiece to direct and apply the cutting stream of water; this is typically sterile saline. It may also assist in the irrigation of the surgical site to help improve site visibility. The system is commonly used to remove burned/damaged skin, tumours, and varicose veins; it may be used endoscopically.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PZP","productCodeName":"Fluid jet removal system"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"60"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-18"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}