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  1. <?xml version="1.0" encoding="UTF-8"?><gudid xmlns="http://www.fda.gov/cdrh/gudid" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" version="1.0" xsi:schemaLocation="http://www.fda.gov/cdrh/gudid gudid.xsd">
  2. <header>
  3. <database frequency="monthly" id="1980" type="FULL">
  4. <downloadFile part="1" totalParts="63"/>
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  8. <creationDate>2018-01-01T03:30:00</creationDate>
  9. <period end="2018-01-01T03:30:00" start="2014-09-24T00:00:00"/>
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  11. <device xmlns="http://www.fda.gov/cdrh/gudid" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
  12. <deviceRecordStatus>Published</deviceRecordStatus>
  13. <devicePublishDate>2016-09-08</devicePublishDate>
  14. <deviceCommDistributionEndDate>2016-12-06</deviceCommDistributionEndDate>
  15. <deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus>
  16. <identifiers>
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  18. <deviceId>XXXX50980089</deviceId>
  19. <deviceIdType>Primary</deviceIdType>
  20. <deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency>
  21. <containsDINumber xsi:nil="true"/>
  22. <pkgQuantity xsi:nil="true"/>
  23. <pkgDiscontinueDate xsi:nil="true"/>
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  26. </identifier>
  27. </identifiers>
  28. <brandName>OCTAGON Infinity TL RP ALLIGATOR Abutment angled, 15°, H 3.0 mm</brandName>
  29. <versionModelNumber>5098008</versionModelNumber>
  30. <catalogNumber>5098008</catalogNumber>
  31. <companyName>Hager & Meisinger Gesellschaft mit beschränkter Haftung</companyName>
  32. <deviceCount>1</deviceCount>
  33. <deviceDescription>TL RP ALLIGATOR Abutment angled, 15°, H 3.0 mm for OCTAGON Infinity Dental Implant TL</deviceDescription>
  34.  
  35. <MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus>
  36. <rx>true</rx>
  37. <otc>false</otc>
  38. <contacts>
  39. <customerContact>
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  42. <email>kathystrange@acesurgical.com</email>
  43. </customerContact>
  44. </contacts>
  45. <gmdnTerms>
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  47. <gmdnPTName>Dental implant suprastructure, permanent</gmdnPTName>
  48.  
  49. </gmdn>
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  51. <productCodes>
  52. <fdaProductCode>
  53. <productCode>NHA</productCode>
  54. <productCodeName>Abutment, Implant, Dental, Endosseous</productCodeName>
  55. </fdaProductCode>
  56. </productCodes>
  57. <deviceSizes/>
  58. <environmentalConditions/>
  59. <sterilization>
  60. <deviceSterile>false</deviceSterile>
  61. <sterilizationPriorToUse>true</sterilizationPriorToUse>
  62. <methodTypes>
  63. <sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod>
  64. </methodTypes>
  65. </sterilization>
  66. </device>
  67. <device xmlns="http://www.fda.gov/cdrh/gudid" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
  68. <deviceRecordStatus>Published</deviceRecordStatus>
  69. <devicePublishDate>2016-09-09</devicePublishDate>
  70. <deviceCommDistributionEndDate xsi:nil="true"/>
  71. <deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus>
  72. <identifiers>
  73. <identifier>
  74. <deviceId>XXXX50980079</deviceId>
  75. <deviceIdType>Primary</deviceIdType>
  76. <deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency>
  77. <containsDINumber xsi:nil="true"/>
  78. <pkgQuantity xsi:nil="true"/>
  79. <pkgDiscontinueDate xsi:nil="true"/>
  80. <pkgStatus xsi:nil="true"/>
  81. <pkgType xsi:nil="true"/>
  82. </identifier>
  83. </identifiers>
  84. <brandName>OCTAGON Infinity TL RP ALLIGATOR Abutment angled, 15°, H 1.5 mm</brandName>
  85. <versionModelNumber>5098007</versionModelNumber>
  86. <catalogNumber>5098007</catalogNumber>
  87. <companyName>Hager & Meisinger Gesellschaft mit beschränkter Haftung</companyName>
  88. <deviceCount>1</deviceCount>
  89. <deviceDescription>TL RP ALLIGATOR Abutment angled, 15°, H 1.5 mm for OCTAGON Infinity Dental Implant TL</deviceDescription>
  90. <MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus>
  91. <rx>true</rx>
  92. <otc>false</otc>
  93. <contacts>
  94. <customerContact>
  95. <phone>+1(508)588-3100</phone>
  96. <phoneExtension xsi:nil="true"/>
  97. <email>kathystrange@acesurgical.com</email>
  98. </customerContact>
  99. </contacts>
  100. <gmdnTerms>
  101. <gmdn>
  102. <gmdnPTName>Dental implant suprastructure, permanent</gmdnPTName>
  103. </gmdn>
  104. </gmdnTerms>
  105. <productCodes>
  106. <fdaProductCode>
  107. <productCode>NHA</productCode>
  108. <productCodeName>Abutment, Implant, Dental, Endosseous</productCodeName>
  109. </fdaProductCode>
  110. </productCodes>
  111. <deviceSizes/>
  112. <environmentalConditions/>
  113. <sterilization>
  114. <deviceSterile>false</deviceSterile>
  115. <sterilizationPriorToUse>true</sterilizationPriorToUse>
  116. <methodTypes>
  117. <sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod>
  118. </methodTypes>
  119. </sterilization>
  120. </device></gudid>
  121.  
  122. identifiers/identifier/deviceId versionModelNumber catalogNumber companyName gmdnTerms/gmdn/gmdnPTName
  123. XXXX50980089 5098008 5098008 Hager & Meisinger Gesellschaft mit beschränkter Haftung Dental implant suprastructure, permanent
  124. XXXX50980079 5098007 5098007 Hager & Meisinger Gesellschaft mit beschränkter Haftung Dental implant suprastructure, permanent
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