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This is the quickest way to find a Product Code. Enter a word from the product name or a keyword associated with the product name. For example, if you are coding swordfish you can enter 'sword' 'fish', or 'swordfish.'
a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. Learn More...
Welcome to the Product Code Builder (PCB) API Usage Documentation page. The documentation provides information regarding how the API retrieves the FDA product code information based upon the code portions selected for each of the five components (Industry, Class, Subclass, PIC, and Group) using the various REST Endpoints.
a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. learn more...
Product Code: OMP: Premarket Review: Office of Surgical and Infection Control Devices (OHT4) Plastic and Reconstructive Surgery Devices (DHT4B) Submission Type: ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press;
Scroll through the list of industries and select the one that is most closely related to the product you are coding. You may select more than one industry by holding down the CTRL key as you make your selections.
Classification Product Code: OBJ : Date Received: 06/29/2020: Decision Date: 03/05/2021: ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press; Combination Products; Advisory Committees;
Product Code: RFT: Device Class: Not Classified Total Product Life Cycle (TPLC) ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press; Combination Products; Advisory Committees;
The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.
Enter a single word (e.g., laser), an exact phrase (e.g., laser light show) or multiple words. To Search by Product, Radiation Type, Product Code, Product Description or Performance Standard select Go To Advanced Search button. Learn More...