FDA Medical Device Registration Form 1. Establishment Details * Establishment Name * Street Address * City * State * Country * Postal Code FDA Registration Number DUNS Number 2. Establishment Contact * Name of Contact Person * Job Title * Mailing Address * City * State * Country * Postal Code * Tel Number * E-Mail Other business Names 3. Type of Operation Manufacturer Contract Manufacturer Contract Sterilizer Specification Developer Initial Importer Foreign Exporter Relabeler Other (Explain) 4. US Importer / Distributor US Importer Name FDA Registration Number DUNS Number Address E-mail Tel Number 5.1 Device Listing Information - 1 * Proprietary Name * Common Name Device Class Device Code 510 (K) Number 5.2 Device Listing Information - 2 Proprietary Name Common Name Device Class Device Code 510 (K) Number 5.3 Device Listing Information - 3 Proprietary Name Common Name Device Class Device Code 510 (K) Number 5.4 Device Listing Information - 4 Proprietary Name Common Name Device Class Device Code 510 (K) Number 5.5 Device Listing Information - 5 Proprietary Name Common Name Device Class Device Code 510 (K) Number 6. US FDA Medical Device Registration Form Submitter Information Submitter Name Job Title Submitter E-mail Your message was sent successfully. You can make the annual payment online now. Domestic and all international customers pay here with 4.7% convenience fee Indian customers pay here with 18% GST