{"publicDeviceRecordKey":"a6762b5f-65c1-48c4-bf45-4b8cbfd833e6","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2021-02-05T00:00:00.000Z","devicePublishDate":"2017-05-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D765KIT0010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Resorba Suture Sample Pack","versionModelNumber":"KIT001","catalogNumber":null,"dunsNumber":"123853058","companyName":"Osteogenics Biomedical Inc","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38000","gmdnPTName":"Nylon suture, non-bioabsorbable, monofilament","gmdnPTDefinition":"A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"},{"gmdnCode":"13908","gmdnPTName":"Polyglycolic acid suture","gmdnPTDefinition":"A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Obsolete"},{"gmdnCode":"17246","gmdnPTName":"Polyglyconate suture","gmdnPTDefinition":"A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from polyglyconate (prepared from a copolymer of glycolic acid and trimethylene carbonate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (especially in paediatric cardiovascular surgeries). It may include an attached needle intended to be disposed of after single use. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"25"},"storageHandlingLow":{"unit":"Degrees Celsius","value":""},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}