Type Indicates the Regulatory Authority assigning the Submission Number. Regulatory Authorization or Marketing Number A number issued when the medical device can be legally marketed. Type Indicates the Regulatory Authority assigning the Regulatory Authorization or Marketing Number. Regulatory Authorization or Marketing Status A decision or action assigned by the Regulatory Authority that indicates the marketing availability of the medical device. Type Indicates the Regulatory Authority assigning the Regulatory Authorization or Marketing Status. Index Brand/Trade/Proprietary, 10, 11 Regulated Entity Address, 13 Catalog/Reference (REF), 10, 11 Regulated Entity Identifier, 13 Common name, 10, 11 Regulated Entity Information, 13 Contains Biological Material, 14 Regulated Entity Name, 13 Device Identifier, 10, 12 Regulatory Authorization or Marketing Expiration Date, 12 Number, 11, 15 Kit, 10, 13 Regulatory Authorization or Marketing Lot or Batch Number, 10, 12 Status, 11, 15 Manufacturing Date, 10, 12 Regulatory Information, 11, 15 Medical Device Identity, 10, 11, 13 Reusable - Multi-Patient Use Device, Medical Device Name, 10, 11 10, 14 Medical Device Risk Classification, 11, Reusable - Single Patient Use Device, 15 10, 14 Medical Device System, 10, 14 Serial Number, 10, 12 Medical Device Type, 11, 15 Single Use Device, 10, 14 Medical Device Usage, 10, 14 Software or Firmware, 10, 12 Method of Sterilization, 10, 15 Sterilization Information, 10, 14 Model, 10, 11 Submission Number, 11, 15 Need for Sterilization Before Use, 14 Supplied Sterile, 10, 14 Production Identifier, 10, 12 Unique Device Identifier, 10, 12
Type Indicates the Regulatory Authority assigning the Submission Number. Regulatory Authorization or Marketing Number A number issued when the medical device can be legally marketed. Type Indicates the Regulatory Authority assigning the Regulatory Authorization or Marketing Number. Regulatory Authorization or Marketing Status A decision or action assigned by the Regulatory Authority that indicates the marketing availability of the medical device. Type Indicates the Regulatory Authority assigning the Regulatory Authorization or Marketing Status. Index Brand/Trade/Proprietary, 10, 11 Catalog/Reference (REF), 10, 11 Common name, 10, 11 Contains Biological Material, 14 Device Identifier, 10, 12 Expiration Date, 12 Kit, 10, 13 Lot or Batch Number, 10, 12 Manufacturing Date, 10, 12 Medical Device Identity, 10, 11, 13 Medical Device Name, 10, 11 Medical Device Risk Classification, 11, 15 Medical Device System, 10, 14 Medical Device Type, 11, 15 Medical Device Usage, 10, 14 Method of Sterilization, 10, 15 Model, 10, 11 Need for Sterilization Before Use, 14 Production Identifier, 10, 12 Regulated Entity Address, 13 Regulated Entity Identifier, 13 Regulated Entity Information, 13 Regulated Entity Name, 13 Regulatory Authorization or Marketing Number, 11, 15 Regulatory Authorization or Marketing Status, 11, 15 Regulatory Information, 11, 15 Reusable - Multi-Patient Use Device, 10, 14 Reusable - Single Patient Use Device, 10, 14 Serial Number, 10, 12 Single Use Device, 10, 14 Software or Firmware, 10, 12 Sterilization Information, 10, 14 Submission Number, 11, 15 Supplied Sterile, 10, 14 Unique Device Identifier, 10, 12