Medical Device Establishment US Agent

$179 / year

This dataset contains the Medical Device Establishment US Agent Information. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.

Complexity

Information about a foreign establishment’s U.S. agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS) system and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

Date Created

2013

Last Modified

2019-11-25

Version

2019-11-25

Update Frequency

Weekly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

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

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

US Agent MD, Establishment US Agent, Medical Device US Agents, Medical Device Accounts

Other Titles

Medical Device US Agent, MD Establishment US Agent

NameDescriptionTypeConstraints
Registration_KeyRegistration Key of the Establishmentintegerlevel : Nominal required : 1
NameName of the US agentstring-
Business_NameName of the businessstring-
Phone_Area_CodeUS agent Phone Area Codestring-
Phone_NumberUS agent phone numberstring-
Phone_ExtensionUS agent Phone Number Extensionstring-
Fax_Area_CodeUS agent Fax Area Codestring-
Fax_NumberUS agent Fax Numberstring-
Email_AddressUS agent Email Addressstring-
Registration KeyNameBusiness NamePhone Area CodePhone NumberPhone ExtensionFax Area CodeFax NumberEmail Address
7571KARL NITTINGERDENTSPLY SIRONA INC717.08494424.0717.08494343.0Karl.Nittinger@dentsplysirona.com
7575KARL NITTINGERDENTSPLY SIRONA INC717.08494424.0717.08494343.0Karl.Nittinger@dentsplysirona.com
5910Yangjun XingStarkey Hearing Technologies952.09474635.0yangjun_xing@starkey.com
9057SUSIE S CHENKARL STORZ ENDOSCOPY-AMERICA, INC.424.02188201.0424.02188519.0su.chen@karlstorz.com
9058SUSIE S. CHENKARL STORZ ENDOSCOPY-AMERICA, INC.424.02188201.0424.02188519.0su.chen@karlstorz.com
6872Corey MurreyColgate-Palmolive Company732.08787500.06274.0corey_murrey@colpal.com
8964Shannon McMurreyEssilor of America, Inc214.04964928.0smcmurrey@essilorusa.com
9037Wayne Matelski202.08576340.0Wayne.Matelski@arentfox.com
9160Rene Van De ZandeEmergo Global Representation LLC512.03279997.0512.03279998.0USAgent@ul.com
8595SUSAN A HANSONPLEXUS CORP.920.07515491.0susan.hanson@plexus.com