{"publicDeviceRecordKey":"8f6b0fc0-ec9b-482d-9ffd-3ec520d96db1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2021-01-08T00:00:00.000Z","devicePublishDate":"2016-07-27T00:00:00.000Z","deviceCommDistributionEndDate":"2018-06-22T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B09929013370","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"INTEGRATED NEEDLEHOLDER","versionModelNumber":"2901-337","catalogNumber":null,"dunsNumber":"040729840","companyName":"SONTEC INSTRUMENTS, INC.","deviceCount":1,"deviceDescription":"NEEDLE-HOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH RIGHT CURVED/ANGLED LUER LOCK SINGLE-ACTION \n","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":"800-821-7496","phoneExtension":null,"email":"info@sontecinstruments.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K002877","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"12726","gmdnPTName":"Suturing needle holder, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEI","productCodeName":"Electrosurgical, Cutting \u0026 Coagulation \u0026 Accessories"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"330"},"sizeText":null,"sizeString":"Length: 330 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization","Dry Heat Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}