Medical Device Establishment Types

$179 / year

Medical Device Listing Establishment Types dataset contains the description of each Establishment Type ID. For combination products, identify the type of the combination (i.e., drug/device, etc.)

Complexity

Establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Medical Device Listing Establishment Types contains the description of each one of the 12 types of medical devices Establishment.

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

Medical Devices, Devices App, Establishment MD, Establishment Types, Medical Device Establishments, Medical Device Types

Other Titles

Medical Device Establishment Types, MD Establishment Types

NameDescriptionTypeConstraints
Establishment_Type_IdEstablishment Type ID, each ID represent an Establishment Type according to this list:integerlevel : Nominal required : 1
Establishment_DescriptionDescription of each Establishment Type Idstring-
Establishment_Short_DescriptionShort Description of each Establishment Type Idstring-
Establishment Type IdEstablishment DescriptionEstablishment Short Description
1Manufacture Medical Device for Another Party (Contract Manufacturer)Contract Manufacturer
2Sterilize Medical Device for Another Party (Contract Sterilizer)Contract Sterilizer
3Export Device to the United States But Perform No Other Operation on DeviceForeign Exporter
5Manufacture Medical DeviceManufacturer
6Remanufacture Medical DeviceRemanufacturer
7Repack or Relabel Medical DeviceRepackager/Relabeler
8Reprocess Single-Use DeviceReprocessor of Single Use Devices
9Develop Specifications But Do Not Manufacture At This FacilitySpecification Developer
10Manufacture Device in the United States for Export OnlyU.S. Manufacturer of Export Only Devices
11Complaint File Establishment per 21 CFR 820.198Complaint File Establishment