Catalogue number

The catalogue number is what customers reorder by and what the REF symbol on the label points to. It is not the FDA product code, which is a classification code.

value given by the manufacturer to identify a specific medical device or accessory as it relates to its form/fit, function and process (i.e. manufacturing processes requiring differentiation for the end user) Note 1 to entry: A catalogue number shall consist of letters or numbers or a combination of these. Note 2 to entry: For the purposes of this document, commercial product code should not be confused with the US FDA, “product code” or procode classification. Note 3 to entry: Synonyms for catalogue number are “reference number” or “reorder number”. Note 4 to entry: See ISO 20417:2021, Figure 2. [SOURCE: ISO 20417:2021,[15] 3.3, modified — The cross-reference in Note 4 to entry has been revised to be external to this document.]

ISO 15223-1:2021, clause 3.2

value given by the manufacturer to identify a specific medical device or accessory (3.1) as it relates to its form/fit, function and process (i.e., manufacturing processes requiring differentiation for the end user) Note 1 to entry: A catalogue number shall consist of letters or numbers or a combination of these. Note 2 to entry: For the purposes of this document, commercial product code should not be confused with the US FDA ‘product code’ or procode classification. Note 3 to entry: Synonyms for catalogue number are "reference number" or "reorder number". Note 4 to entry: See Figure 2. [SOURCE: IMDRF/GRRP WG/N52: 2019[4], 3.2, modified — added ‘or accessory’ and Notes to entry.]

ISO 20417:2021, clause 3.3