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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.'. If you are coding bottled spring water you can enter 'spring' or 'water.'.
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.
This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information.
The information on this page is current as of Mar 22, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 170.3 Definitions. (a) Secretary means the Secretary of Health and Human Services.
Product Classification. Powered suction pump. For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial ...
Classification Product Code: OBJ : Date Received: 06/29/2020: Decision Date: 03/05/2021: ... Combination Product: No - - Links on this page: Page Last Updated: 09/23/2024. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. ...
Note: The revision of this Import Alert (IA) dated 02/13/2023 updates the reason for alert, guidance section including agency contacts, charge code language, and product description. Changes to the import alert are bracketed by asterisks (***).
Product Description: Veterinary X-Ray Systems Product Code: RCJ: Radiation Type: Ionizing Radiation Safety Report Type Required? Abbreviated Annual Reports Required? Yes Applicable Performance Standard(s) No standard applicable. General Radiological Health requirements apply. [1000-1005] - - Links on this page: Page Last Updated: 09/30/2024 ...
Product Classification. The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens.
TPLC Product Code Report. GMP Exempt? Yes. Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile. Summary Malfunction.