Great question - and you are not alone in this confusion!
A model # is usually assigned to a product family or group and can encompass a range of catalogue numbers.
Some manufacturers use both a model # and a catalogue #, while others just use one or the other. It really depends on the company's product numbering structure and process.
However, the critical point to remember is that each device MUST have a UNIQUE number assigned to it, whether that is a model or catalogue number. It is this unique number that will then be associated to the Device Identitier (UDI-DI).
You can find additional information in the new standard
ISO 20417:2021 MEDICAL DEVICES - INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
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Lena Cordie-Bancroft
Victoria MN
United States
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Original Message:
Sent: 12-Jul-2021 05:42
From: Anonymous Member
Subject: ISO 15223-1: 2021 - Model vs Catalogue Number
This message was posted by a user wishing to remain anonymous
Hi all,
I'm hoping someone can clarify the differences between a catalogue number [REF] and a model number [#], particularly when it comes to labelling.
I imagine there might be a need for both numbering systems at a large multinational company, but would have otherwise assumed that a model number would be listed in a catalogue when it comes to a user re-ordering something?
Under MDR, a UDI must include a device model / reference / or catalogue number, so can I also assume that it would only be mandatory to use one of these two symbols/systems (and include the related info in the UDI) ?