Background

The US FDA’s UDI Final Rule (21 CFR 801.45), requires “[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.” Permanent marking is also referred to as “Direct Marking.” The compliance date for Class II devices was September 24, 2016 for devices to be labeled with its UDI. The compliant date for direct marking newly manufactured and labeled Class II devices was originally September 24, 2018. However, Class II devices remaining in Ortho Organizers’ inventory manufactured and labeled prior to the September 2016, the compliance date is September 24, 2019. This means any device remaining in inventory as of September 25, 2019 would need to be reworked to have both a UDI compliant label and direct mark (if required).

FDA publishes enforcement discretion for direct marketing requirements

FDA has since published an enforcement discretion guidance allowing device labelers to provide a process for users to “derive” a device’s UDI at the point of use. Certain information must already be “marked” on a device in order for a UDI to be derived. These are a device’s part/catalog number, or lot number or both part/catalog and lot numbers. FDA also allowed for use of a device’s serial number to be used, but Ortho Organizers does not use serial numbers on the devices subject to this enforcement discretion. Ortho Organizers also uses a device’s part/catalog number as its version/model number. Devices whose UDI can be derived, will not need to be direct marked per the published Enforcement Discretion.

Ortho Organizers has submitted product information to FDA’s Global Unique Device Identification Database (GUDID – https://accessgudid.nlm.nih.gov/) about its devices including each device’s part/catalog number. You will need access to a computer with Internet capabilities to be able to use the methods outlined here for constructing a device’s UDI.

What do I do if I cannot find my device in GUDID?

If after following this process, you are still unable to locate the device in GUDID, contact Ortho Organizers Customer Service 888-851-0533 or [email protected] with your purchase order number for additional assistance. 

Constructing a UDI

Ortho Organizers uses GS1 Specifications to construct UDI’s used on Ortho Organizers devices. GS1 requires “Application Identifiers” (AI) before each UDI segment. These AI are:

Primary DI Number
(17) Expiration Date
(11) Manufacturing Date
(10) Lot Number
(21) Serial Number

A UDI is constructed by joining the Primary DI Number, Lot Number, Serial Number, Expiration Date or Manufacturing Date (as applicable) together

Ortho Organizers products where the UDI can be derived only have a Primary DI Number and Lot Number

Example: (01) 10381780435310 (10) 123456

Determining my device’s UDI

Depending on what is marked on your device, choose one of the below and follow the instructions provided.

  1. Part/Catalog Number only on Device
  2. Lot Number only on Device
  3. Part/Catalog Number and Lot Number on Device
  4. Correlation of Part/Catalog Number on Device to GUDID Database


Part/Catalog Number only on Device

  • Identify part/catalog number marked on product
  • Access GUDID Database:https://accessgudid.nlm.nih.gov
  • Search for part/catalog number in GUDID database; e.g., “205-106”
  • You may need to search the returned listings for the exact device
  • Click on the correct listing to open
  • Copy “Primary DI Number”
  • Contact Ortho Organizers Customer Service at 888-851-0533 or [email protected] with your purchase order number to obtain the Lot Number for your particular device
  • Construct your device’s UDI by joining the Primary DI Number and Lot Number together, using the appropriate GS1 Application Identifiers
    Example: (01) 00190707081577 (10) 123456
  • Record your device’s UDI per your facility’s requirements


Lot Number only on Device

  • Identify lot number marked on the product
  • Locate a copy of the purchase order or Ortho Organizers Invoice to identify your devices part/catalog number
  • If the part/catalog number is not on one of these documents, contact Ortho Organizers Customer Service 888-851-0533 or [email protected] with your purchase order number to obtain
  • Record part/catalog number from purchase order/invoice
  • Access GUDID Database: https://accessgudid.nlm.nih.gov
  • Search for part/catalog number in GUDID database; e.g., 204-101
  • You may need to search the returned listings for the exact device
  • Copy “Primary DI Number”
  • Construct your device’s UDI by joining the Primary DI Number and Lot Number together, using the appropriate GS1 Application Identifiers
    Example: (01) 00190707064976 (10) M11
  • Record your device’s UDI per your facility’s requirements


Part/Catalog Number and Lot Number on Device

  • Identify part and lot numbers marked on product
  • Access GUDID Database: https://accessgudid.nlm.nih.gov
  • Search for part/catalog number in GUDID database; e.g., 201-507
  • You may need to search the returned listings for the exact device
  • Click on the correct listing to open
  • Copy “Primary DI Number”
  • Construct your device’s UDI by joining the Primary DI Number and Lot Number together, using the appropriate GS1 Application Identifiers
    Example: (01) 00190707097431 (10) 0321A
  • Record your device’s UDI per your facility’s requirements


Correlation of Part/Catalog Number on Device to GUDID Database

  • If you are having difficulties searching for the Primary DI Number, use the advance search function, using a partial part number.
  • Access GUDID Database: https://accessgudid.nlm.nih.gov
  • Search for part number in GUDID database using the advanced search feature (click on red down arrow and select “Advanced Search”)
  • Search In = “Version or Model”; For = “terms that begin with”; Query = “Enter beginning of part number. Do not enter letters.” Click on the “Search” button.
  • Locate item in search results. NOTE: Please verify the description matches your device.
  • Copy “Primary DI Number”
  • Contact Ortho Organizers Customer Service 888-851-0533 or [email protected] with your purchase order number to obtain the Lot Number for your particular device
  • Please note in the above example, the Version or Model is the same as Catalog Number
  • Construct your device’s UDI by joining the Primary DI Number and Lot Number together, using the appropriate GS1 Application Identifiers
    Example: (01) 00190707040772 (10) 123456
  • Record your device’s UDI per your facility’s requirements