- US Medical Device Listing Product Code
- MD Listing Product Code
- Product Code
- Medical Device Listing
- Medical Device Codes
- Medical Device Products
Medical Device Listing Product Code
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.
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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).
About this Dataset
John Snow Labs; U.S. Food and Drug Administration (FDA);
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Product Code, Medical Device Listing, Medical Device Codes, Medical Device Products
US Medical Device Listing Product Code, MD Listing Product Code
|Registration_Key_Value||Key value related to Registration Listing ID of the Establishment||integer||level : Nominalrequired : 1|
|Product_Code||The medical device product code||string||required : 1|
|Created_Date||Product code creation date||date||required : 1|
|Owner_Operator_Number||Registration status ID||integer||level : Nominalrequired : 1|
|Registration Key Value||Product Code||Created Date||Owner Operator Number|