<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>02139d8d-43fd-4447-8409-913645d6b577</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-07-12</publicVersionDate><devicePublishDate>2024-07-04</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08904428748198</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08906039313222</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Laminated Box</pkgType></identifier><identifier><deviceId>08906039313222</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>OSSEOUS Gelatin Sponge Strip </brandName><versionModelNumber>E91108020</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>930270428</dunsNumber><companyName>EON MEDITECH PRIVATE LIMITED</companyName><deviceCount>1</deviceCount><deviceDescription>&quot;Absorbable Haemostatic Gelatin Sponge is a sterile malleable, water-insoluble,
Gelatin absorbable sponge intended for haemostatic use by applying to a bleeding surface. Absorbable Haemostatic Gelatin Sponge is non-pyrogenic and biocompatible. Absorbable Haemostatic Gelatin Sponge is a surgical haemostatic sponge, manufactured from highly purified first grade gelatin material for use in various surgical procedures. When implanted in vivo and used in appropriate amounts, it is completely absorbed within 3-4 weeks. When applied to bleeding mucosal regions, it liquefies within 2 to 5 days.
Absorbable Haemostatic Gelatin Sponge have a porous structure which activates the thrombocytes at the moment blood comes in contact with the matrix of the sponge. This causes the thrombocytes to release a series of substances which promote their aggregation at the same time as their surfaces change character, thus enabling them to act as a catalyst for the formation of the fibrin.
&quot;
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>48170</gmdnCode><gmdnPTName>Gelatin haemostatic agent</gmdnPTName><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.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LAY</productCode><productCodeName>Methotrexate Control Materials</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="80"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="20"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Height</sizeType><size unit="Millimeter" value="10"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="30"/><storageHandlingLow unit="Degrees Celsius" value="5"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>