{"publicDeviceRecordKey":"7ca0eb19-c5a5-4b89-9301-4ccb87582618","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-12-14T00:00:00.000Z","devicePublishDate":"2021-07-27T00:00:00.000Z","deviceCommDistributionEndDate":"2023-12-12T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04260293130198","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"04260293133199","pkgQuantity":20,"pkgDiscontinueDate":"2023-12-12","pkgStatus":"Not in Commercial Distribution","pkgType":"Suture Box"},{"deviceId":"04260293133199","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"04260293137197","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"04260293130198","pkgQuantity":12,"pkgDiscontinueDate":"2023-12-12","pkgStatus":"Not in Commercial Distribution","pkgType":"Transport Box"}]},"brandName":"GELITA-SPON® STANDARD","versionModelNumber":"GS-950","catalogNumber":null,"dunsNumber":"330774063","companyName":"GELITA MEDICAL GmbH","deviceCount":1,"deviceDescription":"The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral\ncharacter in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by\ntamponade effect, blood absorption and platelet aggregation following ENT surgery. It is insoluble in water and fully absorbable.\nIts porous structure and interstices enables the product to absorb more than 35 times its own weight of blood and fluids. The absorptive\ncapacity of GELITA-SPON® is a function of its physical size, increasing as the amount of gelatine increases. It is supplied in several sizes.\nIt is packaged individually in (double) blister, pouch or jar/container packaging, sterilized by gamma rays, and is for single use only.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"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":"48170","gmdnPTName":"Gelatin haemostatic agent","gmdnPTDefinition":"A sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LYA","productCodeName":"Splint, Intranasal Septal"},{"productCode":"KHJ","productCodeName":"Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"200"},"sizeText":null,"sizeString":"Length: 200 Millimeter"},{"sizeType":"Height","size":{"unit":"Micrometer","value":"500"},"sizeText":null,"sizeString":"Height: 500 Micrometer"},{"sizeType":"Depth","size":{"unit":"Millimeter","value":"70"},"sizeText":null,"sizeString":"Depth: 70 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store at room temperature, keep dry and away from sunlight"}]},"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":[]}}