<?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>a678c4e7-e928-4720-9586-424265c077d5</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2026-04-20</publicVersionDate><devicePublishDate>2023-07-13</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B097IMD009LLO1</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Himplant Pre-Formed Penile Silicone Block</brandName><versionModelNumber>Large - Extra Long - Semi Soft</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>080156251</dunsNumber><companyName>INTERNATIONAL MEDICAL DEVICES, INC.</companyName><deviceCount>1</deviceCount><deviceDescription xsi:nil="true"/><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Safe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>3106522600</phone><phoneExtension xsi:nil="true"/><email>info@intlmeddevices.com</email></customerContact><customerContact><phone>3106522600</phone><phoneExtension xsi:nil="true"/><email>reports@himplant.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>45230</gmdnCode><gmdnPTName>Silicone-block tissue reconstructive material</gmdnPTName><gmdnPTDefinition>A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MIB</productCode><productCodeName>Elastomer, Silicone Block</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>