<?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>17a13822-69e5-4e29-8b83-7fb13d3b2137</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2020-06-25</publicVersionDate><devicePublishDate>2016-08-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>04715309129364</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>04715309129456</containsDINumber><pkgQuantity>50</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>BOX</pkgType></identifier><identifier><deviceId>04715309129456</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>NA</brandName><versionModelNumber>OS265BA-1-W</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>657528899</dunsNumber><companyName>PANPAC MEDICAL CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>These Cervical Dilators are especially useful in locating and dilating the external OS, the cervical canal and the internal OS.  They are particularly valuable instruments to be used on post-menopausal patients with cervical stenosis.
</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><customerContact><phone>+866286472242</phone><phoneExtension xsi:nil="true"/><email>service@panpac.com.tw</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>58389</gmdnCode><gmdnPTName>Corpus cavernosum dilator, single-use</gmdnPTName><gmdnPTDefinition>A sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of plastic; it is available in a set of graduated sizes that are applied in succession. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HDQ</productCode><productCodeName>Dilator, Cervical, Fixed Size</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>