Medical Device Listing Product Code

$179 / year

This dataset contains Medical Device Listing Product Code information. Classification product codes are a method of internally classifying and tracking medical devices. CDRH and a subset of CBER regulated medical device product codes consist of a 3 letter combination which associates a device’s type with a product classification designated for the application. The information associated with these devices, such as names and attributes, are assigned by CDRH to support their regulation.

Complexity

Classification product codes are a key element in the reporting of adverse events and product problems in medical device reports (MDRs). Though not clearly requested in the 3500A mandatory reporting form (MedWatch Form), it is common practice for the reporter to indicate the product code along with the common name of the device in section D2 of the 3500A form. The addition of the product code by mandatory reporters supports 21 CFR 803.52(c)(2) by describing the type of product. The classification product code used by reporters should be the primary product code associated with the device for which the report is being made. To improve the quality of MDRs, we recommend that reporters include the premarket submission number (if applicable) in section G5 of the 3500A form to further link the device to its original classification.
In cases where the classification product code is not known by the reporter and an MDR is submitted without one, CDRH assigns the appropriate product code to the MDR based on the brand name (section D1), common device name (section D2), or premarket submission number (section D5). However, it is preferred that the reporter of the MDR provide the product code with which CDRH classified the device (in the case of Class II and III devices).

Date Created

2013

Last Modified

2019-06-24

Version

2019-06-24

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

Product Code, Medical Device Listing, Medical Device Codes, Medical Device Products

Other Titles

US Medical Device Listing Product Code, MD Listing Product Code

NameDescriptionTypeConstraints
Registration_Key_ValueKey value related to Registration Listing ID of the Establishmentintegerrequired : 1 level : Nominal
Product_CodeThe medical device product codestringrequired : 1
Created_DateProduct code creation datedaterequired : 1
Owner_Operator_NumberRegistration status IDintegerrequired : 1 level : Nominal
Registration_Key_ValueProduct_CodeCreated_DateOwner_Operator_Number
2034845173FMH1978-01-152417536
1277128997FYF1994-09-222417536
1277128997FYF1994-09-222417536
1277128997FYF1994-09-222417536
1277128997FYF1994-09-222417536
1277128997FYF1994-09-222417536
1277128997FYF1994-09-222417536
1277128997FYF1994-09-222417536
1277128997FYF1994-09-222417536
1277128997FYF1994-09-222417536