constructing a device’s unique device identifier (udi) · • construct your device’s udi by...
TRANSCRIPT
Constructing a device’s Unique Device Identifier (UDI)
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 Integra’s 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 Marking 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 Integra does not use serial numbers on the
devices subject to this enforcement discretion. Integra 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.
Integra 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?
Device Class Manufactured & Labeled Prior to:
Direct Mark Compliance Date (new inventory)
Direct Mark Compliance Date (existing inventory)
Class II (non-sterile devices only)
September 24, 2018 September 24, 2018 September 24, 2019 (unless UDI can be derived)
Class I & Unclassified September 24, 2022 September 24, 2022 September 24, 2022 (unless UDI can be derived)
On a number of Integra devices, the part/catalog number marked on the device does not
exactly match the part/catalog number entered in GUDID (e.g., 119-117 marked on device
versus 119-117ND in GUDID). The process for finding these items in GUDID is described here.
If after following this process, you are still unable to locate the device in GUDID, contact Integra
Customer Service 800-654-2873 or [email protected] with your purchase order
number for additional assistance.
Constructing a UDI
• Integra uses GS1 Specifications to construct UDI’s used on Integra devices. GS1 requires
“Application Identifiers” (AI) before each UDI segment. These AI are:
(01) 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
• Integra 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
1. 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., “4-18”
• You may need to search the returned listings for the exact device
• Click on the correct listing to open
• Copy "Primary DI Number"
• Contact Integra Customer Service at 800-654-2873 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) 10381780435310 (10) 123456
• Record your device’s UDI per your facilities requirements
2. Lot Number only on Device • Identify lot number marked on product
• Locate a copy of the purchase order or Integra Invoice to identify your devices
part/catalog number
• If part/catalog number is not on one of these documents, contact Integra
Customer Service 800-654-2873 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., 505-232
• 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) 10381780158370 (10) 125847
• Record your device’s UDI per your facilities requirements
3. 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., 19-384
• 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) 10381780419860 (10) 1194625
• Record your device’s UDI per your facilities requirements
4. Correlation of Part/Catalog Number on Device to GUDID Database • Identify part/catalog number marked on product
• 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 Integra Customer Service at 800-654-2873 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) 10381780051428 (10) 123456
• Record your device’s UDI per your facilities requirements