Others titles
- Medical Device Owner Operator
- MD Establishment Owner Operator
Keywords
- Owner Operator MD
- Establishment Owner Operator
- Medical Device Operators
- Medical Device Establishment Owners
Medical Device Establishment Owner Operator
The U.S. Food and Drug Administration (FDA) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA.
The operators of such establishments are found in this dataset.
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Description
All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee. The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012.
This official list of operator is updated weekly according to FDA releasing.
About this Dataset
Data Info
Date Created | 2013 |
---|---|
Last Modified | 2024-06-10 |
Version | 2024-06-10 |
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 | Owner Operator MD, Establishment Owner Operator, Medical Device Operators, Medical Device Establishment Owners |
Other Titles | Medical Device Owner Operator, MD Establishment Owner Operator |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Registration_Key | Registration Key of the Establishment | integer | level : Nominalrequired : 1 |
Contact_Id | Contact Id | integer | level : Nominal |
Firm_Name | Firm Name | string | - |
Owner_Operator_Number | Owner Operator Number | string | - |
Data Preview
Registration Key | Contact Id | Firm Name | Owner Operator Number |
5 | 948632 | BARNHARDT MFG. CO. | 1010842 |
6 | 948632 | BARNHARDT MFG. CO. | 1010842 |
16 | 3395481 | CORDIS CORPORATION | 1016427 |
17 | 3395481 | CORDIS CORPORATION | 1016427 |
21 | 948646 | MEDICAL SPECIALTIES, INC. | 1016498 |
51 | 2916370 | Smith & Nephew, Inc. | 1020279 |
55 | 2916370 | Smith & Nephew, Inc. | 1020279 |
79 | 948692 | PROFESSIONAL PRODUCTS, INC. | 1026765 |
155 | 1954733 | PETER BRASSELER HOLDINGS, L.L.C. | 1032227 |
157 | 948813 | THE QUALITY ASSURANCE SERVICE CORP. | 1032263 |