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gtin (global trade item number)

  1. Ed Panek

    GTIN (Global Trade Item Number) for non CE Mark

    Hello, We are attempting to move some production to a new supplier for USA shipment only. Our current product is manufactured and has CE approval and marking on the device. The new device will be USA only, lower cost and no CE marking. I know we need a new SKU for this item but does it need a...
  2. N

    Will an FDA UDI be compatible with a European MDR UDI?

    Does anyone know whether an FDA UDI will be (or can be) compatible with a UDI required by the EU MDR? If not, will manufacturers be able to label their device with both UDI's?
  3. Sam Lazzara

    GS1 introduces Global Model Numbers for Medical Devices

    On 2017-09-07, GS1 introduced something new (I think) - Global Model Numbers (GMN). The detailed requirements are provided in the recently published GS1 General Specifications (Release 18, Ratified Jan 2018). Here is some information from Release 18: The GMN includes the GS1 Company Prefix...
  4. Pmarszal

    Two Questions on UDI Product Description (GS1 US and GTIN aspects)

    Hello, The community has been very helpful to answer questions about UDI/GUDID in the past but wanted to ask a question that some of you may be able to answer. We created a GTIN number with GS1 US that we use as our DI number for a specific part. We since changed the part description...
  5. Marc

    GTIN - Global Trade Item Number

    gtin - Global Trade Item Number Global Trade Item Number (GTIN) is an identifier for trade items developed by GS1 (comprising among others of the former EAN International and Uniform Code Council).[1] Such identifiers are used to look up product information in a database (often by entering...
  6. SteveK

    Does anyone know what a healthcare GDSN data pool actually looks like?

    As with a previous post on GS1 and PEPPOL relating to the UK's NHS requirements, there is also the matter of Global Data Synchronization Network data pools. They would appear to be a type of catalogue with descriptions of e.g. a medical device against its GTIN. This is where we will have to...
  7. I

    UDI requirements vs Japanese Barcode Marking guideline

    Hello everyone, According to the Japanese Barcode Marking Guideline, 3 information could be required to be encoded in a MD barcode: its product code (e.g. GTIN), its serial number and its expiration date, if applicable. Looking at US FDA UDI requirements in terms of labeling, the product...
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