{"publicDeviceRecordKey":"ae96e39e-34b2-4db3-bc32-7dd52bc3283e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-08-21T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00842331106927","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Novo Surgical","versionModelNumber":"9000-34053RM","catalogNumber":"9000-34053RM","dunsNumber":"033029433","companyName":"NOVO SURGICAL, INC.","deviceCount":1,"deviceDescription":"Debakey/Maryland Dissector - 3 Piece Modular Reusable Insert, insert only, 5.0 mm sheath diameter, atraumatic, double action, 13\" (33.0 cm)","DMExempt":false,"premarketExempt":false,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(877)860-6686","phoneExtension":null,"email":"info@novosurgical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K974382","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35080","gmdnPTName":"Rigid endoscopic tissue manipulation forceps, reusable","gmdnPTDefinition":"A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GCJ","productCodeName":"Laparoscope, general \u0026 plastic surgery"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"33"},"sizeText":null,"sizeString":"Length: 33 Centimeter"}]},"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}