Medical Device Model Number

Medical Device Databases | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Apr 6, 2022

UDI Basics | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics

Lot or batch number within which a device was manufactured Serial number of a specific device Expiration date of a specific device Date a specific device …

FAQs about the New Device Registration and Listing …

https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements

Product Code Classification Database | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code …

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

https://www.greenlight.guru/blog/iso-15223-1-2021-fourth-edition

A model number can represent a product family or cover multiple catalogue numbers. At least one is required. Some manufacturers place both on the device …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Step 1: Determine if your product meets the definition of a medical device per Section 201 (h) of the Food, Drug & Cosmetic Act. Step 2: Determine if an …

Labeling Symbols | Medtronic Diabetes

https://www.medtronicdiabetes.com/labeling-symbols

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. ISO 7000- 2493: Graphical symbols for use on equipment. EN …

Medical Device Classification Product Codes

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff

Premarket Approval (PMA) Devices and Humanitarian Device Exemption (HDE) Devices The use of product codes for PMA and HDE devices is similar to their use for 510 (k) …

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - Clinical Mercury Thermometer. Once you find your device in the panel's beginning list, go …

How to find the Medical Device Listing Number (MDL Number) …

https://elsmar.com/elsmarqualityforum/threads/how-to-find-the-medical-device-listing-number-mdl-number-from-the-fda-website.45979/

Medical Devices, Medical Information Technology, Medical Software and Health Informatics Medical Device Related Regulations US Medical Device Regulations …