Medical Device Non-Registered Importers Identified by Manufacturers

$79 / year

This dataset shows establishments that are required to register with the Food and Drug Administration (FDA) that are also required to list the devices that are made there and the activities that are performed on those devices.

Complexity

Medical Device Non-Registered Importers Identified by Manufacturers dataset contains details of Non-Registered Importers of medical devices including full address and phone numbers. The Safe Medical Devices Act (SMDA) requires FDA to issue regulations requiring distributors to report device-related deaths, serious injuries and reportable malfunctions. On September 1, 1993, FDA published a final MDR reporting regulation for distributors, including provisions for importers that became effective on October 1, 1993. In addition, the SMDA requires distributors and manufacturers to certify to FDA the number of MDR reports filed or that no reports have been filed.

Date Created

2013

Last Modified

2018-07-16

Version

2018-07-16

Update Frequency

Weekly

Temporal Coverage

N/A

Spatial Coverage

USA

Source

John Snow Labs => U.S. Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

Source License Requirements

Open for commercial use

Source Citation

N/A

Keywords

Non-Registered Importers, Medical Device Importers, Medical Device Non-Registered Importers, Medical Device Manufacturers

Other Titles

Medical Device Non-Registered Importers, MD Non-Registered Importers, MD Non-Registered Importers Identified by Manufacturers

Name Description Type Constraints
Registration_KeyEstablishment Registration Keyintegerlevel : Nominal
Registration_Key_ValueThe Establishment Registration Key Valueintegerrequired : 1 level : Nominal
Importer_Address_IdMedical device importer address Idintegerrequired : 1 level : Nominal
Duns_NumberDuns Numberintegerlevel : Nominal
Business_NameBusiness Namestring-
Address_Line_1Requriedstring-
Address_Line_22nd line of the Address of the importer,string-
CityCity of the importerstring-
State_AbbreviationState Idstring-
Zip_CodeZip Code of the importerstring-
CountryCountry Name of the importerstring-
Email_AddressEmail Address of the importerstring-
Phone_Area_CodeBus Phone Area Codeintegerlevel : Nominal
Phone_NumberBus Phone Numintegerlevel : Nominal
Phone_ExtensionBus Phone Extnintegerlevel : Nominal
Fax_Area_CodeFax Area Codeintegerlevel : Nominal
Fax_NumberFax Numintegerlevel : Nominal
Importer_TypeImporter Typestring-
Subdivision_CodeSubdivision Codestring-
Postal_CodePostal Codestring-
Phone_Country_CodeBus Phone Country Codeintegerlevel : Nominal
Fax_Country_CodeFax Country Codeintegerlevel : Nominal
Registration_KeyRegistration_Key_ValueImporter_Address_IdDuns_NumberBusiness_NameAddress_Line_1Address_Line_2CityState_AbbreviationZip_CodeCountryEmail_AddressPhone_Area_CodePhone_NumberPhone_ExtensionFax_Area_CodeFax_NumberImporter_TypeSubdivision_CodePostal_CodePhone_Country_CodeFax_Country_Code
572621119269868226733M103 Milbury St.AuburnMA1501UNITED STATES
572621149595474226733M103 Milbury St.AuburnMA1501UNITED STATES
68180119537802422332AMAZON.COMDallasDallasTX75241UNITED STATES11
169063206163805215701Penny Winn180 G StForksWA98331UNITED STATES
217522124208535326368Edwin Bae770 2nd AveTroyNY12182UNITED STATES
217522148331785326368Edwin Bae770 2nd AveTroyNY12182UNITED STATES
217522169362876826368Edwin Bae770 2nd AveTroyNY12182UNITED STATES
217522103393969626368Edwin Bae770 2nd AveTroyNY12182UNITED STATES
217522154392241726368Edwin Bae770 2nd AveTroyNY12182UNITED STATES
217522205323897826368Edwin Bae770 2nd AveTroyNY12182UNITED STATES